Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00016211 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.
PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
- Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy.
- Compare the quality of life and survival of these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the health economics associated with this study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days.
- Arm II: Patients receive no further therapy after completion of prior chemotherapy.
Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.
Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 287 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer |
| Study Start Date : | February 2001 |
| Actual Primary Completion Date : | March 2006 |
- Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
- Quality of life assessed by EORTC QLQ-C30 and EORTC BN-20 at baseline, 6 weeks, every 3 months in year 1, and then every 6 months
- Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months
- Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Cytologically or histologically confirmed small cell lung cancer
- Documented extensive disease before the initiation of chemotherapy
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Responsive disease after 4 to 6 courses of initial chemotherapy
- No more than 5 weeks since completion of prior chemotherapy
- No brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- No prior radiotherapy to the brain
- No prior radiotherapy to the head and neck
Surgery:
- Not specified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016211
Show 49 study locations
| Study Chair: | B.J. Slotman, PhD, MD | Free University Medical Center | |
| Study Chair: | Pieter E. Postmus, MD | Free University Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00016211 |
| Other Study ID Numbers: |
EORTC-22993-08993 EORTC-RA-22993 EORTC-LCG-08993 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | September 24, 2012 |
| Last Verified: | September 2012 |
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extensive stage small cell lung cancer |
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Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |