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Brief Title † | Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer | ||||||||||||
Official Title † | A Phase III Trial Of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed By Maintenance Therapy With ZD 1839 Or Placebo In Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer | ||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous). Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks. Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses. Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.
Patients are followed every 6 months for 5 years and then annually for 5 years. PROJECTED ACCRUAL: A total of 840 patients will be accrued for this study within 3.5 years. |
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Study Phase | Phase III | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control | ||||||||||||
Primary Outcome Measure † | |||||||||||||
Secondary Outcome Measure † | |||||||||||||
Condition † | Lung Cancer | ||||||||||||
Intervention † | Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: gefitinib Procedure: radiation therapy |
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MEDLINE PMIDs | 18378568 | ||||||||||||
Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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Recruitment Information Fields | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Enrollment † | |||||||||||||
Start Date † | June 2001 | ||||||||||||
Completion Date | |||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Gender | Both | ||||||||||||
Ages | |||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States, Canada | ||||||||||||
Administrative Information Fields | |||||||||||||
NCT ID † | NCT00020709 | ||||||||||||
Organization ID | CDR0000068706 | ||||||||||||
Secondary IDs †† | SWOG-S0023, CAN-NCIC-BR15, NCCTG-S0023 | ||||||||||||
Study Sponsor † | Southwest Oncology Group | ||||||||||||
Collaborators †† | National Cancer Institute (NCI) North Central Cancer Treatment Group National Cancer Institute of Canada |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | November 2004 | ||||||||||||
First Received Date † | July 11, 2001 | ||||||||||||
Last Updated Date | July 23, 2008 |