Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With Small Cell Lung Cancer
|First Received Date ICMJE||March 3, 2001|
|Last Updated Date||September 16, 2013|
|Start Date ICMJE||September 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Overall survival (OS) at 3 years|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00011921 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With Small Cell Lung Cancer|
|Official Title ICMJE||Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell transplant or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell or bone marrow transplant is more effective than chemotherapy alone in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (limited disease vs extensive disease with vs without liver metastases), performance status (0 vs 1), gender, LDH level (normal vs abnormal), and participating center. Patients are randomized to 1 of 2 treatment arms.
Within 28 days of the start of the second course of induction chemotherapy, patients receive high-dose ifosfamide IV over 17 hours, carboplatin IV over 3 hours, and etoposide phosphate IV over 3 hours on days 1-4. At 48 hours after completion of high-dose chemotherapy, patients undergo autologous PBSC or bone marrow transplantation and then receive G-CSF SC for 14 days. Treatment repeats every 28 days for 3 courses.
After completion of high-dose or standard chemotherapy, patients with limited disease or extensive disease in complete remission receive thoracic radiotherapy daily on days 1-5 for 6 weeks. All patients in complete remission receive prophylactic cranial radiotherapy daily on days 1-5 for 3 weeks.
Quality of life is assessed at baseline, at the beginning of courses 1 and 3 (high-dose chemotherapy) or courses 3 and 5 (standard chemotherapy), and then at 7, 12, and 18 months.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 430 patients (215 per treatment arm) will be accrued for this study within 3 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Lung Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||430|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 65 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Switzerland|
|Removed Location Countries|
|NCT Number ICMJE||NCT00011921|
|Other Study ID Numbers ICMJE||CDR0000068379, EBMT-RANDOM-ICE, EU-98001, NCI-V01-1645|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||EBMT Solid Tumors Working Party|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||March 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP