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

NCT03481114 | Completed Phase 2 Results DMC FDA Device

• 1 other identifier: 2017-8065
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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 Positron Emission Tomography (PET) findings.

Conditions

Non-small Cell Lung Cancer

Keywords

radiation therapy; chemotherapy; PET Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Locoregional Progression-free Survival

  Weeks 19, 32, and 45 on study

• Progression-free Survival (PFS)

  Weeks 19, 32 and 45 on study

• Overall Survival (OS)

  Up to 45 weeks

• Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0

  From treatment start through study week 45

• Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time

  From treatment start through study week 45

Study Arms (2)

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).

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.

Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy

Interventions

PET-based, dose-painted, accelerated chemoradiotherapy COMBINATION_PRODUCT

Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.

PET-based, dose-painted, accelerated chemoradiotherapy,

Standard chemoradiotherapy COMBINATION_PRODUCT

Patients in this arm will receive a standard radiotherapy course.

Standard chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Key limitations of this study include its modest sample size and the fact that it was conducted at a single institution. Although most local disease recurrences tend to occur in the first few years after chemoradiotherapy, longer follow-up will be helpful to ensure that disease control rates using our experimental regimen are acceptable.

Results Point of Contact

• Title: Dr. Nitin Ohri
• Organization: Albert Einstein College of Medicine

nitin.ohri@einsteinmed.edu

718-405-8550

Study Officials

• Nitin Ohri, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: August 28, 2017
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)