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Combination Chemotherapy and Radiation Therapy
Accelerated Chemoradiotherapy for Non-Small Cell Lung Cancer (REPAINT Trial)
Phase 2
Waitlist Available
Led By Nitin Ohri, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18
Pathologically proven diagnosis of NSCLC with specified stages
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start through 5 years post treatment
Awards & highlights
REPAINT Trial Summary
This trial is testing whether a shorter, 4-week course of radiation therapy, when combined with chemotherapy, is as effective as the standard 6-week course of radiation therapy for patients with locally-advanced non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of locally-advanced non-small cell lung cancer (NSCLC). They must be able to read and write in the languages available for the PROCTCAE tool, have an ECOG Performance Status of 0-2, and meet specific diagnostic criteria. Women should not be pregnant or breastfeeding and must agree to use contraception.Check my eligibility
What is being tested?
The study compares two chemoradiotherapy approaches for NSCLC: a standard 6-week course versus a shorter, intense 4-week course guided by PET scans. Patients are randomly assigned to one of these treatments to see which is better based on their own reported outcomes during and after treatment.See study design
What are the potential side effects?
Chemoradiotherapy can cause fatigue, nausea, skin irritation at the radiation site, difficulty swallowing, changes in taste or appetite, coughing or shortness of breath. Long-term effects may include scarring in the lungs or heart complications.
REPAINT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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My lung cancer is confirmed and its stage is identified.
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I can take care of myself and am up and about more than half of the day.
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I have completed all required tests, including PET/CT and brain MRI or CT.
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My blood tests show my organs and bone marrow are working well.
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I have not had chemotherapy or chest radiation for lung cancer.
REPAINT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start through 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start through 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chemoradiotherapy
Secondary outcome measures
Grade 3-5 adverse events, scored using CTCAE v. 4
Locoregional progression-free survival
Overall survival
+3 moreREPAINT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PET-based, dose-painted, accelerated chemoradiotherapy,Experimental Treatment1 Intervention
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
Group II: Standard chemoradiotherapyActive Control1 Intervention
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Find a Location
Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,158 Total Patients Enrolled
Nitin Ohri, MDPrincipal InvestigatorMontefiore Medical Center
6 Previous Clinical Trials
421 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.My fluid buildup in the chest or heart area is not cancerous or too small to sample.My lung cancer is confirmed and its stage is identified.My diabetes is not well-controlled, with fasting glucose over 200 mg/dL.I am not pregnant, breastfeeding, and I am using contraception.I can take care of myself and am up and about more than half of the day.I have completed all required tests, including PET/CT and brain MRI or CT.My blood tests show my organs and bone marrow are working well.I have not had chemotherapy or chest radiation for lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Standard chemoradiotherapy
- Group 2: PET-based, dose-painted, accelerated chemoradiotherapy,
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in the experiment?
"Affirmative. Per clinicaltrialas.gov, this medical experiment is currently looking for volunteers; it was first announced on August 28th 2017 and subsequently updated July 18th 2022. The project needs 50 participants from 1 healthcare facility."
Answered by AI
Are there any vacant positions available in this medical research?
"According to clinicaltrials.gov, this experiment is presently recruiting candidates as of July 18th 2022. The trial was first reported on August 28th 2017."
Answered by AI
What potential hazards should one be aware of when receiving PET-based, dose-painted, accelerated chemoradiotherapy?
"Our team's assessment of the safety of PET-based, dose-painted, accelerated chemoradiotherapy is a 2. This score was given because this Phase 2 trial has some evidence for safety but none for efficacy."
Answered by AI
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