Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer (REPAINT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03481114|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy Combination Product: Standard chemoradiotherapy||Phase 2|
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:
- PET-based, dose-painted, accelerated chemoradiotherapy over 4 weeks (20 radiotherapy fractions)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules|
|Actual Study Start Date :||August 28, 2017|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Active Comparator: Standard chemoradiotherapy
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).
Combination Product: Standard chemoradiotherapy
Patients in this arm will receive a standard radiotherapy course.
Experimental: PET-based, dose-painted, accelerated chemoradiotherapy,
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.
Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy
Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
- PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy [ Time Frame: 6 Weeks after initiation of Chemoradiation ]
- Locoregional progression-free survival [ Time Frame: Weeks 19, 32 and 45 on study ]Lack of local disease progression based on repeat imaging
- Progression-free survival [ Time Frame: Weeks 19, 32 and 45 on study ]Lack of any disease progression based on repeat imaging
- Overall survival [ Time Frame: From treatment start through 5 years post treatment ]Follow ups will be maintained with study patients to determine survival status
- Grade 3-5 adverse events, scored using CTCAE v. 4 [ Time Frame: From treatment start through study week 45 ]Evaluation of any side effects or toxicities using a standard grading system
- PRO-CTCAE adverse events with score ≥ 3 at any time [ Time Frame: From treatment start through study week 45 ]Evaluation of severe, patient reported side effects or toxicities
- PRO-CTCAE adverse events with any score [ Time Frame: From treatment start through study week 45 ]Evaluation of any patient reported side effects or toxicities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481114
|Contact: Sarah Yukelisfirstname.lastname@example.org|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Sarah Yukelis 718-920-7750 email@example.com|
|Principal Investigator: Nitin Ohri, MD|
|Principal Investigator:||Nitin Ohri, MD||Montefiore Medical Center|