Brief Summary
This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy regimens, such as FOLFIRINOX (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, and oxaliplatin), or CAPOX (capecitabine and oxaliplatin) use more than one anticancer drug that work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate for the primary rectal tumor and lead to higher rates of clinical complete response (and thus a chance to avoid surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Brief Title
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course radiotherapy (LCRT) followed by neoadjuvant modified leucovorin fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT followed by neoadjuvant modified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6)/CAPOX (Phase II).
II. To evaluate and compare disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6/CAPOX. (Phase III)
SECONDARY OBJECTIVES:
I. To evaluate and compare organ-preservation-time (OPT) between two treatment arms.
II. To evaluate and compare time to distant metastasis between two treatment arms.
III. To evaluate and compare overall survival (OS) between two treatment arms. IV. To evaluate and compare toxicity profiles of total neoadjuvant therapy (TNT) between two treatment arms.
V. To evaluate and compare sustained cCR between two treatment arms.
EXPLORATORY OBJECTIVE:
I. Evaluation of circulating tumor deoxyribonucleic acid (ctDNA) kinetics during neoadjuvant therapy \& surveillance and to correlate with radiographic, pathologic, and clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I:
LCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive either FOLFOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV bolus over 2-4 minutes and IV continuous infusion over 46-48 hours on day 1 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle or CAPOX consisting of capecitabine orally on days 1-14 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle. Treatment with FOLFOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Treatment with CAPOX repeats every 3 weeks for up to 5 cycles (15 weeks) in the absence of disease progression or unacceptable toxicity.
ARM II:
LCRT: Patients undergo long course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive FOLFIRINOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV continuous infusion over 46-48 hours on day 1 of each cycle, oxaliplatin IV over 2 hours on day 1 of each cycle, and irinotecan IV over 30-90 minutes on day 1 of each cycle) Treatment with FOLFIRINOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity.
All patients undergo CT scan, MRI scan, and collection of blood samples, and sigmoidoscopy throughout the trial and undergo biopsy during screening.
I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course radiotherapy (LCRT) followed by neoadjuvant modified leucovorin fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT followed by neoadjuvant modified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6)/CAPOX (Phase II).
II. To evaluate and compare disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6/CAPOX. (Phase III)
SECONDARY OBJECTIVES:
I. To evaluate and compare organ-preservation-time (OPT) between two treatment arms.
II. To evaluate and compare time to distant metastasis between two treatment arms.
III. To evaluate and compare overall survival (OS) between two treatment arms. IV. To evaluate and compare toxicity profiles of total neoadjuvant therapy (TNT) between two treatment arms.
V. To evaluate and compare sustained cCR between two treatment arms.
EXPLORATORY OBJECTIVE:
I. Evaluation of circulating tumor deoxyribonucleic acid (ctDNA) kinetics during neoadjuvant therapy \& surveillance and to correlate with radiographic, pathologic, and clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I:
LCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive either FOLFOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV bolus over 2-4 minutes and IV continuous infusion over 46-48 hours on day 1 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle or CAPOX consisting of capecitabine orally on days 1-14 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle. Treatment with FOLFOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Treatment with CAPOX repeats every 3 weeks for up to 5 cycles (15 weeks) in the absence of disease progression or unacceptable toxicity.
ARM II:
LCRT: Patients undergo long course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive FOLFIRINOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV continuous infusion over 46-48 hours on day 1 of each cycle, oxaliplatin IV over 2 hours on day 1 of each cycle, and irinotecan IV over 30-90 minutes on day 1 of each cycle) Treatment with FOLFIRINOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity.
All patients undergo CT scan, MRI scan, and collection of blood samples, and sigmoidoscopy throughout the trial and undergo biopsy during screening.
Completion Date
Completion Date Type
Estimated
Conditions
STAGE II RECTAL CANCER AJCC V8
STAGE III RECTAL CANCER AJCC V8
LOCALLY ADVANCED RECTAL ADENOCARCINOMA
Eligibility Criteria
Inclusion Criteria:
* Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)
* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
* Tumor site: Rectum; distal edge of the tumor =\< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment)
* No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal cancer (even if done for diagnostic purposes) are allowed (e.g., transanal excision \[open or minimally invasive\], local excision, endoscopic submucosal dissection or endoscopic submucosal resection).
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
\* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min
\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* No upper rectal tumors (i.e., distal portion of tumor must be =\> 12 cm from the anal verge)
* No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis or prior endoscopic submucosal dissection
* No known mismatch repair deficient rectal adenocarcinoma
* HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
* Testing for dihydropyrimidine dehydrogenase (DPD) deficiency is not required. However, when available, patients with complete lack of DPD should not be treated with fluoropyrimidines (such patients must not be enrolled or if initiated on therapy and noted to have fluoropyrimidine related toxicities be taken off protocol; dose reductions for patients with partial deficiency may be done per local guidelines
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* Once systemic chemotherapy has been completed and the patient is either in surveillance or being considered for surgery then medically necessary CYP3A4 medications can be resume
* Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)
* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
* Tumor site: Rectum; distal edge of the tumor =\< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment)
* No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal cancer (even if done for diagnostic purposes) are allowed (e.g., transanal excision \[open or minimally invasive\], local excision, endoscopic submucosal dissection or endoscopic submucosal resection).
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
\* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min
\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* No upper rectal tumors (i.e., distal portion of tumor must be =\> 12 cm from the anal verge)
* No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis or prior endoscopic submucosal dissection
* No known mismatch repair deficient rectal adenocarcinoma
* HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
* Testing for dihydropyrimidine dehydrogenase (DPD) deficiency is not required. However, when available, patients with complete lack of DPD should not be treated with fluoropyrimidines (such patients must not be enrolled or if initiated on therapy and noted to have fluoropyrimidine related toxicities be taken off protocol; dose reductions for patients with partial deficiency may be done per local guidelines
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* Once systemic chemotherapy has been completed and the patient is either in surveillance or being considered for surgery then medically necessary CYP3A4 medications can be resume
Inclusion Criteria
Inclusion Criteria:
* Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)
* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
* Tumor site: Rectum; distal edge of the tumor =\< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment)
* No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal cancer (even if done for diagnostic purposes) are allowed (e.g., transanal excision \[open or minimally invasive\], local excision, endoscopic submucosal dissection or endoscopic submucosal resection).
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
\* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min
\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* No upper rectal tumors (i.e., distal portion of tumor must be =\> 12 cm from the anal verge)
* No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis or prior endoscopic submucosal dissection
* No known mismatch repair deficient rectal adenocarcinoma
* HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
* Testing for dihydropyrimidine dehydrogenase (DPD) deficiency is not required. However, when available, patients with complete lack of DPD should not be treated with fluoropyrimidines (such patients must not be enrolled or if initiated on therapy and noted to have fluoropyrimidine related toxicities be taken off protocol; dose reductions for patients with partial deficiency may be done per local guidelines
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* Once systemic chemotherapy has been completed and the patient is either in surveillance or being considered for surgery then medically necessary CYP3A4 medications can be resume
* Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)
* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
* Tumor site: Rectum; distal edge of the tumor =\< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment)
* No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal cancer (even if done for diagnostic purposes) are allowed (e.g., transanal excision \[open or minimally invasive\], local excision, endoscopic submucosal dissection or endoscopic submucosal resection).
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
\* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min
\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* No upper rectal tumors (i.e., distal portion of tumor must be =\> 12 cm from the anal verge)
* No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis or prior endoscopic submucosal dissection
* No known mismatch repair deficient rectal adenocarcinoma
* HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
* Testing for dihydropyrimidine dehydrogenase (DPD) deficiency is not required. However, when available, patients with complete lack of DPD should not be treated with fluoropyrimidines (such patients must not be enrolled or if initiated on therapy and noted to have fluoropyrimidine related toxicities be taken off protocol; dose reductions for patients with partial deficiency may be done per local guidelines
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* Once systemic chemotherapy has been completed and the patient is either in surveillance or being considered for surgery then medically necessary CYP3A4 medications can be resume
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05610163
Org Class
Other
Org Full Name
Alliance for Clinical Trials in Oncology
Org Study Id
A022104
Overall Status
Active, not recruiting
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-free Survival in Patients With Locally Advanced Rectal Cancer
Primary Outcomes
Outcome Description
Defined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If an nCR evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. Difference of proportions test will be conducted to compare cCR rate in the experimental arm to cCR rate in the control arm. If the one-sided p-value of the comparison is \< 0.05 (difference in proportion \> 9.3%), then we will conclude the cCR rate in the experimental arm is superior to the control arm.
Outcome Measure
Clincal Complete Response (cCR) Rates (Phase II)
Outcome Time Frame
Up to 5 years
Outcome Description
Defined as the time from date of randomization to the date of first occurrence of the following events: death due to all causes, tumor that recurs locally after an R0 total mesorectal excision (TME), tumor that regrows after an initial apparent clinical and radiological CR and cannot be surgically removed with an R0 TME, and M1 disease diagnosed at any point after the initiation of treatment. Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Outcome Measure
Disease-free survival (DFS) rate (Phase III)
Outcome Time Frame
From date of randomization, assessed up to 5 years
Secondary Ids
Secondary Id
U10CA180821
Secondary Id
NCI-2022-07800
Secondary Id
NRG-GI010
Secondary Outcomes
Outcome Description
Defined as time from the date of randomization to the date of the first occurrence of the following events: TME performed or attempted, tumor that regrows after an initial apparent clinical and radiological complete response (CR) and death due to all causes. Will be estimated, in each arm, using the method of Kaplan-Meier and treatment compared by a stratified Cox regression model.
Outcome Time Frame
From date of randomization, assessed up to 5 years
Outcome Measure
Organ-preservation time (OPT)
Outcome Description
Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Outcome Time Frame
From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years
Outcome Measure
Time to distant metastasis (TDM)
Outcome Description
Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
Outcome Time Frame
From the date of randomization to the date of death due to all causes, assessed up to 5 years
Outcome Measure
Overall survival (OS)
Outcome Description
Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The overall adverse event rates for grade 3 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).
Outcome Time Frame
Up to 5 years
Outcome Measure
Incidence of adverse events (AEs)
Outcome Description
Defined as a binary endpoint with two statuses: responder and non-responder. Responders are defined as those evaluable patients who achieved at least one of the following within 3 years after randomization:
* Had TME and the pathologic outcome is pathologic complete response
* Had a cCR, were on watch and wait (WW) with no regrowth and no distant metastases
* Had nCR, were on WW with no regrowth and no distant metastases Non-responders are defined as all patients who did not meet the criteria as noted above for the responders.
* Had TME and the pathologic outcome is pathologic complete response
* Had a cCR, were on watch and wait (WW) with no regrowth and no distant metastases
* Had nCR, were on WW with no regrowth and no distant metastases Non-responders are defined as all patients who did not meet the criteria as noted above for the responders.
Outcome Time Frame
Up to 5 years
Outcome Measure
Sustained cCR
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Chaoyuan Kuang
Investigator Email
chaoyuan.kuang@einsteinmed.edu
Investigator Phone
617-398-1715
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Please Specify
Categories Mesh Debug
Colorectal Cancer --- COLORECTAL NEOPLASMS
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
MeSH Terms
RECTAL NEOPLASMS
COLORECTAL NEOPLASMS
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
INTESTINAL DISEASES
RECTAL DISEASES
CAPECITABINE
FLUOROURACIL
LEUCOVORIN
IRINOTECAN
OXALIPLATIN
MAGNETIC RESONANCE SPECTROSCOPY
SIGMOIDOSCOPY
BIOPSY
DEOXYCYTIDINE
CYTIDINE
PYRIMIDINE NUCLEOSIDES
PYRIMIDINES
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
URACIL
PYRIMIDINONES
DEOXYRIBONUCLEOSIDES
NUCLEOSIDES
NUCLEIC ACIDS, NUCLEOTIDES, AND NUCLEOSIDES
FORMYLTETRAHYDROFOLATES
TETRAHYDROFOLATES
FOLIC ACID
PTERINS
PTERIDINES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
COENZYMES
ENZYMES AND COENZYMES
CAMPTOTHECIN
ALKALOIDS
COORDINATION COMPLEXES
ORGANIC CHEMICALS
SPECTRUM ANALYSIS
CHEMISTRY TECHNIQUES, ANALYTICAL
INVESTIGATIVE TECHNIQUES
COLONOSCOPY
ENDOSCOPY, GASTROINTESTINAL
ENDOSCOPY, DIGESTIVE SYSTEM
DIAGNOSTIC TECHNIQUES, DIGESTIVE SYSTEM
DIAGNOSTIC TECHNIQUES AND PROCEDURES
DIAGNOSIS
ENDOSCOPY
DIAGNOSTIC TECHNIQUES, SURGICAL
DIGESTIVE SYSTEM SURGICAL PROCEDURES
SURGICAL PROCEDURES, OPERATIVE
MINIMALLY INVASIVE SURGICAL PROCEDURES
CYTODIAGNOSIS
CYTOLOGICAL TECHNIQUES
CLINICAL LABORATORY TECHNIQUES
SPECIMEN HANDLING