Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Etoposide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)

• T4, any N, M0 or any T, N3, M0

• No N3 disease due to scalene or supraclavicular lymph node involvement

• No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement

• No mixed tumor types with small cell lung cancer

• At least 1 unidimensionally measurable target lesion

• At least 20 mm by conventional techniques OR

• At least 10 mm by spiral CT scan

• No pre-existing pleural or pericardial effusion

• No CNS involvement by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm ^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST/ALT no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.25 times ULN

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No clinical evidence of superior vena cava syndrome

Pulmonary:

• Postoperative FEV1 and KCO greater than 40% predicted

• VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)

Other:

• No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma)

• No active uncontrolled infection requiring IV antibiotics

• No pre-existing sensory neurotoxicity grade 2 or greater

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for NSCLC

• No concurrent immunotherapy during induction chemoradiotherapy

• Concurrent colony stimulating factors allowed

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• No prior surgery for NSCLC

Other:

• No other concurrent anticancer drugs during induction chemoradiotherapy