Brief Summary
This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.
Brief Title
Carbon Ion RT for Locally Advanced Pancreatic Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
* Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
* Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (\>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
* No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
* ECOG Performance Status 0-1 within 30 days prior to registration
* Age ≥ 18
* CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
* Additional laboratory studies within 14 days prior to registration demonstrating:
Creatinine \< 2 mg/dl; GFR \> 50 mL/min (Cockroft and Gault formula)
* Bilirubin \< 1.5 x ULN
* ALT and AST ≤ 2.5 x ULN
* aPTT, PT ≤ 1.5 x ULN
* Patients must provide study specific informed consent prior to study entry.
* Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
Exclusion Criteria:
* More than one primary lesion
* Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
* Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years is permitted.
* Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation.
* Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment.
* FOLFIRINOX
* Gemcitabine/nab-paclitaxel
* Gemcitabine
* S-1
* Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields
* Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
* Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
* Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (\>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
* No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
* ECOG Performance Status 0-1 within 30 days prior to registration
* Age ≥ 18
* CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
* Additional laboratory studies within 14 days prior to registration demonstrating:
Creatinine \< 2 mg/dl; GFR \> 50 mL/min (Cockroft and Gault formula)
* Bilirubin \< 1.5 x ULN
* ALT and AST ≤ 2.5 x ULN
* aPTT, PT ≤ 1.5 x ULN
* Patients must provide study specific informed consent prior to study entry.
* Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
Exclusion Criteria:
* More than one primary lesion
* Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
* Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years is permitted.
* Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation.
* Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment.
* FOLFIRINOX
* Gemcitabine/nab-paclitaxel
* Gemcitabine
* S-1
* Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields
Inclusion Criteria
Inclusion Criteria:
* Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
* Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
* Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (\>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
* No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
* ECOG Performance Status 0-1 within 30 days prior to registration
* Age ≥ 18
* CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
* Additional laboratory studies within 14 days prior to registration demonstrating:
Creatinine \< 2 mg/dl; GFR \> 50 mL/min (Cockroft and Gault formula)
* Bilirubin \< 1.5 x ULN
* ALT and AST ≤ 2.5 x ULN
* aPTT, PT ≤ 1.5 x ULN
* Patients must provide study specific informed consent prior to study entry.
* Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
* Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
* Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
* Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (\>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
* No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
* ECOG Performance Status 0-1 within 30 days prior to registration
* Age ≥ 18
* CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
* Additional laboratory studies within 14 days prior to registration demonstrating:
Creatinine \< 2 mg/dl; GFR \> 50 mL/min (Cockroft and Gault formula)
* Bilirubin \< 1.5 x ULN
* ALT and AST ≤ 2.5 x ULN
* aPTT, PT ≤ 1.5 x ULN
* Patients must provide study specific informed consent prior to study entry.
* Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
Gender
All
Gender Based
false
Keywords
pancreatic cancer
carbon ion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04592861
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2020-11511
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective, Randomized, Phase 3 Trial of Carbon Ion Radiation Therapy Versus Standard Care for Locally Advanced Pancreatic Cancer
Primary Outcomes
Outcome Description
The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.
Outcome Measure
Overall survival duration
Outcome Time Frame
The length of time from randomization until death from any cause for up to 24 months
Secondary Outcomes
Outcome Description
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Outcome Time Frame
he length of time from study registration until disease progression at any site or death from any cause, up to 24 months
Outcome Measure
Progression-free survival duration
Outcome Description
A set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment
Outcome Time Frame
Up to 24 months
Outcome Measure
Local disease progression scored using RECIST 1.1 criteria
Outcome Description
A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
Outcome Time Frame
Up to 24 months
Outcome Measure
Adverse events as defined by CTCAE v5.0
Outcome Description
Questionnaire developed to measure the quality of life of cancer patients. Composite scores range from 0 to 100, with higher scores being more favorable.
Outcome Time Frame
up to 24 months
Outcome Measure
Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire
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
Nitin Ohri
Investigator Email
nitin.ohri@einsteinmed.org
Investigator Phone