Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer

NCT04751747 | Recruiting DMC

• 4 other identifiers: Pro2020002153NCI-2020-08292032009P30CA072720
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies the effect of adaptive radiation planning in reducing side effects associated with radiation treatment and immunotherapy in patients with stage II-IV non-small cell lung cancer. Prior to radiation, patients undergo simulation, where they are positioned on the treatment table in a manner that can be reproduced each time they receive treatment in order to reach the tumor exactly at the same spot each time. However, a patient's tumor may shrink as they receive radiation, exposing healthy tissue to radiation as well. Adaptive radiation planning involves re-designing a treatment plan at set intervals. The purpose of this study is to see whether establishing set time points through adaptive radiation planning, regardless of whether the doctor notices a significant decrease in tumor size, will reduce some of the side effects associated with radiation treatment and immunotherapy.

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Unresectable Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates

  Will be analyzed using a one-sided z-test to determine if reduction in radiation doses to organs at risk compared will result in a lower rate of pneumonitis compared to historical controls.

  At 6 months post chemoradiation

Secondary Outcomes (5)

• Determine if adaptive radiation therapy reduces radiation doses to heart and lung

  Baseline up to day 29 of treatment

• Dosimetric changes in lung, heart, and esophageal dosimetry parameters in patients treated with adaptive radiation planning

  Baseline up to day 29 of treatment

• Change in toxicities, including cardiac and esophageal toxicities

  Baseline up to 25 months after chemoradiation

• Toxicity correlation to disease-free survival (DFS)/progression-free survival (PFS)/overall survival (OS)

  Up to 25 months after chemoradiation

• Tumor volume reduction

  Up to 25 months after chemoradiation

Study Arms (1)

Supportive care (CT simulation, contrast agent)

EXPERIMENTAL

Patients undergo CT stimulation with or without IV contrast over 1.5 hours on days -15 to -1, then undergo SOC chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29.

Procedure: Computed Tomography; Other: Contrast Agent

Interventions

Computed Tomography PROCEDURE

Undergo CT simulation

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Supportive care (CT simulation, contrast agent)

Contrast Agent OTHER

Given IV

Also known as: Contrast, Contrast Drugs, contrast material, Contrast Medium

Supportive care (CT simulation, contrast agent)

Eligibility Criteria

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

You may qualify if:

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
• Histologically or cytological evidence of locally advanced, biopsy-proven, stage II (inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with chemoradiation with concurrent or adjuvant immunotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and marrow laboratory values for radiation therapy deemed by appropriate the investigator obtained within 14 days prior to registration for protocol therapy
• Women of childbearing potential (WOCBP) must obtain a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) at day -30 to day 0
• Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception during the time of the study period
• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year

You may not qualify if:

• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator
• Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
• Active central nervous system (CNS) metastases (if symptomatic or without prior brain imaging, subjects must undergo a head computed tomography \[CT\] scan or brain magnetic resonance imaging \[MRI\] within 28 days prior to registration for protocol therapy to exclude brain metastases)
• Treatment with any investigational agent within 28 days prior to registration for protocol therapy
• Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation therapy
• Active second cancers
• History of psychiatric illness or social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Salma K Jabbour

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: February 12, 2021
• Study Start: February 11, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)