Study on Whole-Brain Radiation Therapy With or Without Avoiding the Memory Area in Small Cell Lung Cancer
Sponsor: NRG Oncology
ClinicalTrials ID:NCT02635009
This clinical trial is exploring whether whole-brain radiation therapy, with or without avoiding the memory area of the brain, is more effective in treating small cell lung cancer that is either limited to one lung or has spread to other parts of the body.
Patient Parameters
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Program Overview
The study aims to find out if whole-brain radiation therapy, which uses high-energy x-rays to kill cancer cells, is more effective when the memory area of the brain (hippocampus) is avoided. This could potentially reduce side effects on memory and thinking in patients with small cell lung cancer.
Description
The main goals of this study are to see if avoiding the memory area of the brain during whole-brain radiation therapy is just as effective in preventing cancer from returning in the brain as standard whole-brain radiation therapy. Researchers also want to know if this approach helps preserve memory and thinking abilities better than standard treatment.
Secondary goals include comparing how quickly patients experience cognitive decline, assessing quality of life, and evaluating overall survival rates between the two treatment methods. The study will also look at the cost-effectiveness of the treatments and explore biological markers that might predict cognitive decline.
Participants will be randomly assigned to one of two groups: one group will receive standard whole-brain radiation therapy, and the other group will receive radiation therapy that avoids the memory area. Both treatments will be given daily for two weeks. After treatment, patients will have regular follow-ups to monitor their health and any changes in their condition.
Eligibility Criteria
Exclusion Criteria
- Previous radiation treatment to the head or neck that overlaps with the study area.
- Evidence of cancer spread to the brain or other brain-related conditions.
- Planned chemotherapy during radiation treatment, except for certain allowed medications.
- Other active cancers or cancers treated within the last five years, except for certain skin cancers or in situ carcinomas.
- Conditions that prevent MRI scans, like metal implants or severe claustrophobia.
- Severe health issues, such as recent heart problems, infections requiring IV antibiotics, or severe liver or lung disease.
- Uncontrolled heart rhythm problems.
- HIV positive with low immune cell count, unless under treatment and stable.
- Pregnant or breastfeeding women, or those not using effective birth control, due to potential risks from radiation treatment.
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