Brief Summary
The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using dose-painting based on pre-treatment PET findings.
Brief Title
Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Detailed Description
This study is open for patients with non-small cell lung cancer. This study offers such patients the chance for a shorter and more personalized treatment course utilizing PET imaging.
Patients will be stratified based on performance status and tumor size and randomized to one of two treatment plans:
1. PET-based, dose-painted, accelerated chemoradiotherapy over 4 weeks (20 radiotherapy fractions)
2. Standard chemoradiotherapy over 6 weeks (30 radiotherapy fractions)
All patients will receive standard weekly doses of chemotherapy (carboplatin and paclitaxel) during radiotherapy. This may be followed by adjuvant systemic therapy, at the discretion of the treating physicians.
All patients will undergo standard evaluations prior to enrollment, during treatment, and after treatment. Additionally, patient-reported outcomes will be assessed periodically using a PRO-CTCAE tool.
Patients will be stratified based on performance status and tumor size and randomized to one of two treatment plans:
1. PET-based, dose-painted, accelerated chemoradiotherapy over 4 weeks (20 radiotherapy fractions)
2. Standard chemoradiotherapy over 6 weeks (30 radiotherapy fractions)
All patients will receive standard weekly doses of chemotherapy (carboplatin and paclitaxel) during radiotherapy. This may be followed by adjuvant systemic therapy, at the discretion of the treating physicians.
All patients will undergo standard evaluations prior to enrollment, during treatment, and after treatment. Additionally, patient-reported outcomes will be assessed periodically using a PRO-CTCAE tool.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the AJCC Staging Manual, 7th edition,
Appendix):
* Stage IIIA or IIIB
* Stage II NSCLC with contraindication to curative surgical resection
* Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III
Appropriate diagnostic/staging workup, including:
* Complete history and physical examination
* PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required.
* MRI of the brain or head CT with contrast within 42 days prior to study entry
* No prior chemotherapy or thoracic radiotherapy for lung cancer
* ECOG Performance Status 0-2
* Age \> 18
* Able to read and write in one of the following languages, in which the PROCTCAE tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish
* Laboratory studies obtained within 28 days prior to study entry demonstrating adequate bone marrow and end organ function
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy, agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed,and be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
All patients must sign study specific informed consent prior to study entry.
Exclusion Criteria:
* Pleural or pericardial effusion (A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance.)
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
* Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy
* have a positive pregnancy test at baseline
* are pregnant or breastfeeding
* Poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the AJCC Staging Manual, 7th edition,
Appendix):
* Stage IIIA or IIIB
* Stage II NSCLC with contraindication to curative surgical resection
* Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III
Appropriate diagnostic/staging workup, including:
* Complete history and physical examination
* PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required.
* MRI of the brain or head CT with contrast within 42 days prior to study entry
* No prior chemotherapy or thoracic radiotherapy for lung cancer
* ECOG Performance Status 0-2
* Age \> 18
* Able to read and write in one of the following languages, in which the PROCTCAE tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish
* Laboratory studies obtained within 28 days prior to study entry demonstrating adequate bone marrow and end organ function
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy, agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed,and be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
All patients must sign study specific informed consent prior to study entry.
Exclusion Criteria:
* Pleural or pericardial effusion (A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance.)
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
* Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy
* have a positive pregnancy test at baseline
* are pregnant or breastfeeding
* Poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
Inclusion Criteria
Inclusion Criteria:
Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the AJCC Staging Manual, 7th edition,
Appendix):
* Stage IIIA or IIIB
* Stage II NSCLC with contraindication to curative surgical resection
* Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III
Appropriate diagnostic/staging workup, including:
* Complete history and physical examination
* PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required.
* MRI of the brain or head CT with contrast within 42 days prior to study entry
* No prior chemotherapy or thoracic radiotherapy for lung cancer
* ECOG Performance Status 0-2
* Age \> 18
* Able to read and write in one of the following languages, in which the PROCTCAE tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish
* Laboratory studies obtained within 28 days prior to study entry demonstrating adequate bone marrow and end organ function
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy, agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed,and be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
All patients must sign study specific informed consent prior to study entry.
Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the AJCC Staging Manual, 7th edition,
Appendix):
* Stage IIIA or IIIB
* Stage II NSCLC with contraindication to curative surgical resection
* Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III
Appropriate diagnostic/staging workup, including:
* Complete history and physical examination
* PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required.
* MRI of the brain or head CT with contrast within 42 days prior to study entry
* No prior chemotherapy or thoracic radiotherapy for lung cancer
* ECOG Performance Status 0-2
* Age \> 18
* Able to read and write in one of the following languages, in which the PROCTCAE tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish
* Laboratory studies obtained within 28 days prior to study entry demonstrating adequate bone marrow and end organ function
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy, agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed,and be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
All patients must sign study specific informed consent prior to study entry.
Gender
All
Gender Based
false
Keywords
radiation therapy
chemotherapy
PET Imaging
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03481114
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2017-8065
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules
Primary Outcomes
Outcome Measure
PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy
Outcome Time Frame
6 Weeks after initiation of Chemoradiation
Secondary Outcomes
Outcome Description
Lack of local disease progression based on repeat imaging
Outcome Time Frame
Weeks 19, 32 and 45 on study
Outcome Measure
Locoregional progression-free survival
Outcome Description
Lack of any disease progression based on repeat imaging
Outcome Time Frame
Weeks 19, 32 and 45 on study
Outcome Measure
Progression-free survival
Outcome Description
Follow ups will be maintained with study patients to determine survival status
Outcome Time Frame
From treatment start through 5 years post treatment
Outcome Measure
Overall survival
Outcome Description
Evaluation of any side effects or toxicities using a standard grading system
Outcome Time Frame
From treatment start through study week 45
Outcome Measure
Grade 3-5 adverse events, scored using CTCAE v. 4
Outcome Description
Evaluation of severe, patient reported side effects or toxicities
Outcome Time Frame
From treatment start through study week 45
Outcome Measure
PRO-CTCAE adverse events with score ≥ 3 at any time
Outcome Description
Evaluation of any patient reported side effects or toxicities
Outcome Time Frame
From treatment start through study week 45
Outcome Measure
PRO-CTCAE adverse events with any score
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
516-672-2711