Status:
UNKNOWN
Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Locally Advanced Lung Non-Small Cell Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ca...
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 estab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04751747
Start Date
February 11 2021
End Date
September 1 2025
Last Update
December 13 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
2
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903