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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00006487 |
Purpose
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Drug: tirapazamine Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer |
| Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: Patients are assigned to one of two induction therapy arms.
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.
Patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No malignant pericardial or pleural effusions, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 87 Study Locations| Study Chair: | Quynh-Thu X. Le, MD | Stanford University |
More Information
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00006487 History of Changes |
| Other Study ID Numbers: | CDR0000068318, U10CA032102, SWOG-S0004 |
| Study First Received: | November 6, 2000 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Etoposide phosphate Tirapazamine Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |