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

NCT ID: NCT04751747

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2025-09-01

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue, with the intention of establishing a new standard treatment modality.

OUTLINE:

Patients undergo computed tomography (CT) stimulation with or without intravenous (IV) contrast over 1.5 hours on days -15 to -1, then undergo standard of care (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.

After completion of study, patients are followed up at 3-12 weeks, and then every 6 months for approximately 2 years.

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma; Metastatic 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (CT simulation, contrast agent)

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.

Group Type: EXPERIMENTAL

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT simulation

Contrast Agent

Intervention Type: OTHER

Given IV

Interventions

Computed Tomography

Undergo CT simulation

Intervention Type: PROCEDURE

Contrast Agent

Given IV

Intervention Type: OTHER

Other Intervention Names

CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT; CT Scan; tomography; Contrast; Contrast Drugs; contrast material; Contrast Medium

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Salma Jabbour, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salma K Jabbour

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status: RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Salma K. Jabbour

Role: primary

Salma Jabbour, MD

Role: primary

Other Identifiers

NCI-2020-08292

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro2020002153

Identifier Type: -

Identifier Source: secondary_id

032009

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2020002153

Identifier Type: -

Identifier Source: org_study_id