Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
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|ClinicalTrials.gov Identifier: NCT00005062|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 13, 2014
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain.
PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: radiation therapy||Phase 3|
- Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission.
- Evaluate the quality of life and late sequelae in this patient population treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose.
- Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days).
Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center.
- 18 fractions/24 days (conventional radiotherapy) OR
- 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with isolated brain failure may undergo further radiotherapy.
Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter.
Patients are followed at least every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders|
|Study Start Date :||September 1999|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
- Incidence of brain metastases 2 years after randomization
- Overall survival and disease-free survival 2 years after randomization
- Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter
- Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter
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): NCT00005062
|OverallOfficial:||Cecile Le Pechoux, MD||Gustave Roussy, Cancer Campus, Grand Paris|
|OverallOfficial:||Suresh Senan||Free University Medical Center|