Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003364|
Recruitment Status : Completed
First Posted : January 23, 2004
Last Update Posted : December 19, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with radiation therapy may kill more tumor cells. The best timing for radiation therapy and combination chemotherapy in treating limited stage small cell lung cancer is not yet known .
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Radiation: radiation therapy||Phase 3|
OBJECTIVES: I. Determine whether long term survival is affected by the timing of thoracic radiotherapy in patients with limited stage small cell lung cancer who are receiving combination chemotherapy. II. Determine whether the development of local recurrence and distant metastases are affected by the timing of thoracic radiotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. All patients receive cyclophosphamide, doxorubicin, and vincristine by IV bolus alternating with 3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30 minutes. This treatment alternates every 3 weeks for six courses. Patients are randomized to have thoracic radiotherapy either with course 2 (arm I) or with course 6 (arm II) of chemotherapy. Patients in arm I are given 1 week of rest between radiotherapy and the second course of chemotherapy. If there is no disease progression after chemotherapy and locoregional irradiation, and a repeat brain scan is negative, patients receive prophylactic brain irradiation. Patients are followed monthly for the first year and then every 2 months thereafter.
PROJECTED ACCRUAL: This study will accrue 398 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||398 participants|
|Official Title:||A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)|
|Study Start Date :||January 1993|
|Study Completion Date :||August 2006|
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): NCT00003364
|Ascot, England, United Kingdom, SL5 8AA|
|Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BE|
|Addenbrooke's NHS Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Chelmsford, Essex, England, United Kingdom, CM1 5ET|
|Essex County Hospital|
|Colchester, England, United Kingdom|
|Royal Free Hospital|
|Hampstead, London, England, United Kingdom, NW3 2QG|
|Leeds, England, United Kingdom, LS16 6QB|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Guy's and St. Thomas' Hospitals Trust|
|London, England, United Kingdom, SE1 9RT|
|Charing Cross Hospital|
|London, England, United Kingdom, W6 8RF|
|Middlesex Hospital- Meyerstein Institute|
|London, England, United Kingdom, WIT 3AA|
|Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Peterborough Hospitals Trust|
|Peterborough, England, United Kingdom, PE3 6DA|
|Southend NHS Trust Hospital|
|Westcliff-On-Sea, England, United Kingdom|
|Study Chair:||Stephen G. Spiro||University College London Hospitals|