NCT00005022
Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
PHASE1
COMPLETED
NCT00005022
INTERVENTIONAL
A Phase I/II Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer
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 radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell carcinoma of the lung Limited disease (stage I-IIIb but excluding T4 tumor based on malignant pleural effusion or N3 disease based on contralateral hilar or contralateral supraclavicular involvement) No pericardial or pleural effusion on chest x-ray regardless of cytology Measurable or evaluable disease Tumor must be encompassed by limited radiation therapy fields without causing severe symptomatic pulmonary dysfunction
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic heart disease At least 6 months since prior myocardial infarction Pulmonary: See Disease Characteristics Forced expiratory volume at one second (FEV1) greater than 0.8 L No uncontrolled bronchospasm in unaffected lung Other: No other serious concurrent illness No prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other concurrent malignancy No history of uncontrolled psychiatric illness, severe head injury, chronic alcohol or drug abuse, or central nervous system disease Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior complete tumor resection
Lung Cancer
- TREATMENT
-
- Type: DRUG
- Name: cisplatin
- Description:
- Arm Group Labels: Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6
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- Type: DRUG
- Name: etoposide
- Description:
- Arm Group Labels: Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6
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- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6
- Radiation Therapy Oncology Group