A Phase 3 interventional study of BCG vaccine and monoclonal antibody BEC2 in Lung Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-18.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. BCG may activate the immune system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective treatment for limited-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (60-70% vs 80-100%), and response to first line combined modality treatment (complete remission vs partial remission). Patients are randomized to one of two treatment arms.
Patients are followed at 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 570 patients (285 per treatment arm) will be accrued for this study within 2 years.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 453 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
Completed first line combination treatment consisting of at least a 2 drug chemotherapy regimen (4 to 6 courses) and a chest radiotherapy regimen
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC