Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Squamous cell carcinoma

- Adenocarcinoma, including bronchoalveolar cell carcinoma

- Large cell anaplastic carcinoma, including giant and clear cell carcinoma

- Inoperable stage IIIA or IIIB disease

- No direct invasion of vertebral body

- Tumors adjacent to a vertebral body without bone invasion allowed if all gross
disease can be encompassed in radiotherapy boost field

- Contralateral mediastinal disease (N3) allowed if all gross disease can be
encompassed in radiotherapy boost field

- No scalene, supraclavicular, or contralateral hilar node involvement

- Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be
encompassed in radiotherapy field

- No exudative, bloody, or cytologically malignant pleural effusion

- Evidence of pleural effusion by chest CT scan but not chest x-ray that is too
small to tap allowed

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- The following are not considered measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions in a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- AST less than 2 times upper limit of normal

Renal:

- Creatinine clearance 20-130 mL/min for females

- Creatinine clearance 20-150 mL/min for males

Pulmonary:

- FEV1 at least 1.2 L

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other currently active malignancy (defined as completed prior therapy and
considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except steroids for adrenal failure or septic shock,
hormones for non-disease-related conditions (e.g., insulin for diabetes), or
glucocorticosteroids as antiemetics

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy for NSCLC

Surgery:

- At least 2 weeks since prior exploratory thoracotomy