Non-small Cell Lung CancerPhase 2REPAINTNCT03481114
Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
A Phase 2 study testing PET-based, dose-painted, accelerated chemoradiotherapy and Standard chemoradiotherapy in people with Non-small Cell Lung Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- PET-based, dose-painted, accelerated chemoradiotherapy and Standard chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 27 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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.
Read the 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:
- 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 Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- PET-based, dose-painted, accelerated chemoradiotherapy, Standard chemoradiotherapy
- Keywords
- radiation therapy, chemotherapy, PET Imaging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-based, dose-painted, accelerated chemoradiotherapyCombination product
Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
Standard chemoradiotherapyCombination product
Patients in this arm will receive a standard radiotherapy course.
| Study group | Role | What they receive |
|---|---|---|
| Standard chemoradiotherapy | Active comparator | 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). Receives: Combination Product: Standard chemoradiotherapy |
| PET-based, dose-painted, accelerated chemoradiotherapy, | Experimental | 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. Receives: Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 Weeks after initiation of Chemoradiotherapy
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From treatment start through study week 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start28 Aug 2017
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants were stratified by performance status (2 vs 0-1) and primary tumor size (\> 4cm or \<= 4cm) and then randomized 1:1 to receive either PET-based, dose-painted radiotherapy or standard radiotherapy.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481114
- Sponsor's protocol ID
- 2017-8065
- Acronym
- REPAINT
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2018
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules
- ClinicalTrials.gov ID
- NCT03481114
- Acronym / sponsor ID
- REPAINT / 2017-8065
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- radiation therapy, chemotherapy, PET Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants were stratified by performance status (2 vs 0-1) and primary tumor size (> 4cm or <= 4cm) and then randomized 1:1 to receive either PET-based, dose-painted radiotherapy or standard radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Standard chemoradiotherapy | Active comparator | Combination Product: Standard chemoradiotherapyPatients 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). |
| PET-based, dose-painted, accelerated chemoradiotherapy, | Experimental | Combination Product: PET-based, dose-painted, accelerated chemoradiotherapyFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
- 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
- Complete history and physical examination
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-based, dose-painted, accelerated chemoradiotherapyPatients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging. | Combination product | PET-based, dose-painted, accelerated chemoradiotherapy, |
| Standard chemoradiotherapyPatients in this arm will receive a standard radiotherapy course. | Combination product | Standard chemoradiotherapy |
Primary outcome
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Time frame: Up to 6 Weeks after initiation of Chemoradiotherapy
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.
6 secondary outcomes
Locoregional Progression-free Survival
Time frame: Weeks 19, 32, and 45 on study
Progression-free Survival (PFS)
Time frame: Weeks 19, 32 and 45 on study
Overall Survival (OS)
Time frame: Up to 45 weeks
Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0
Time frame: From treatment start through study week 45
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Time frame: From treatment start through study week 45
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Time frame: From treatment start through study week 45
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Ohri, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET-based, dose-painted, accelerated chemoradiotherapy and Standard chemoradiotherapy in people with Non-small Cell Lung Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 (time frame: Up to 6 Weeks after initiation of Chemoradiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.