Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer (NCT00006344) | Clinical Trial Compass
WithdrawnPhase 3
Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
Stopped: PI left institution
United States0Started 2000-05
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy may be more effective in preventing brain metastases.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year.
Who can participate
Age range
0 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma of the lung diagnosed within the past year Limited stage Must have completed prior chemotherapy with thoracic irradiation Extensive stage Must have completed prior chemotherapy with or without thoracic irradiation No more than 24 Gy of prior prophylactic cranial irradiation to the whole brain No brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy within the past 3 years except the following: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was withdrawn before enrolling any patients — does that mean there were safety concerns, or was it withdrawn for a different reason, and how does that affect my options for preventive brain radiation?
2Since this was a Phase 3 trial studying radiation to prevent brain metastases in small cell lung cancer, can you explain whether prophylactic cranial irradiation is already considered a standard-of-care option for me, given that this study never completed?
3Small cell lung cancer has a high risk of spreading to the brain — what are the current evidence-based approaches to preventing brain metastases that I should be considering, now that this particular trial is no longer available?
4Are there other active clinical trials or completed studies on preventive brain radiation for small cell lung cancer that you would recommend I look into as an alternative to this withdrawn trial?
5What would the realistic time commitment and side effects look like for preventive brain radiation in general, so I can weigh whether pursuing that path — through a different study or standard treatment — fits my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.