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| Descriptive Information Fields | |||||
| Brief Title † | Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer | ||||
| Official Title † | A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited 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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Overall survival at 1 and 2 years [ Designated as safety issue: No ] Progression-free survival and median survival time at 1 year [ Designated as safety issue: No ] Treatment-related and rate of treatment-related fatalities at 2 years [ Designated as safety issue: No ] Response rates (complete response, partial response, progressive disease, and stable disease) 2 months after completion of study treatment [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Lung Cancer | ||||
| Intervention † | Drug: cisplatin Drug: etoposide Procedure: adjuvant therapy Procedure: radiation therapy |
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| MEDLINE PMIDs | |||||
| 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 † | 71 | ||||
| Start Date † | June 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00066222 | ||||
| Organization ID | CDR0000271939 | ||||
| Secondary IDs †† | RTOG-0239 | ||||
| Study Sponsor † | Radiation Therapy Oncology Group | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2006 | ||||
| First Received Date † | August 6, 2003 | ||||
| Last Updated Date | July 23, 2008 | ||||