Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer (REPAINT)

Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules

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 Positron Emission Tomography (PET) findings.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Combination product: Standard chemoradiotherapy; Combination product: PET-based, dose-painted, accelerated chemoradiotherapy

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 Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages according to the American Joint Committee on Cancer (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 (e.g.: 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Age > 18
• Able to read and write in one of the following languages, in which the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Metabolic Tumor Volume (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3	Observation of Grade 3 or higher patient-reported toxicity six weeks after chemotherapy radiation was characterized utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome assessment tool developed by the National Cancer Institute (NCI) to capture symptomatic adverse events in patients on cancer clinical trials. Participants completed a customized PRO-CTCAE survey with 24 questions addressing 12 symptoms at baseline, every two weeks during chemoradiotherapy. The number of patients with PRO-CTCAE Grade 3 or higher adverse events was summarized by study arm for each event type.	Up to 6 Weeks after initiation of Chemoradiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional Progression-free Survival	Locoregional progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of local or regional disease progression or death, whichever comes first, censored at the date of data collection	Weeks 19, 32, and 45 on study
Progression-free Survival (PFS)	Progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of disease progression or death, whichever comes first, censored at the date of data collection. PFS will be summarized by study arm using basic descriptive statistics.	Weeks 19, 32 and 45 on study
Overall Survival (OS)	Follow ups will be maintained with study patients to determine survival status. OS will be assessed during the interval from study registration to death, censored at the date of data collection.	Up to 45 weeks
Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0	Evaluation of any Grade 3-5 adverse events, including Grade 3-5 side effects and toxicities, were assessed based on CTCAE Version 4.0. Adverse events/side effects/toxicities have been summarized by study arm. The number/percentage of patients with Grade 3-5 adverse events, scored using CTCAE Version 4.0, is summarized by study arm.	From treatment start through study week 45
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time	Evaluation of severe, patient reported side effects or toxicities was assessed. The number/percentage of patients with PRO-CTCAE, scored using CTCAE Version 4.0, is summarized by study arm.	From treatment start through study week 45
Number of Patients With PRO-CTCAE Adverse Events With Any Score	Evaluation of any patient reported side effects or toxicities. This Outcome Measure includes PRO-CTCAE AEs that were Grades 0, 1, or 2. The number of patients with Grade 3 PRO-CTCAE have been summarized in the corresponding Outcome Measure.	From treatment start through study week 45

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Nitin Ohri, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; PET Imaging; radiation therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2017-8065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes