Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

• Status: Completed
• Trial end date: 2006-05-01
• 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 before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by 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: Swiss Group for Clinical Cancer Research
• Treatments: Cisplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed, operable stage IIIB non-small cell lung cancer

• T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax

• Squamous cell

• Adenosquamous cell

• Large cell

• Poorly differentiated

• No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan

• No malignant pleural or pericardial effusion

• No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3

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

Hepatic:

• Bilirubin normal

• AST and/or ALT no greater than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No unstable cardiac disease requiring treatment

• No congestive heart failure

• No angina pectoris (even if medically controlled)

• No significant arrhythmia

• No myocardial infarction within the past 3 months

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No definite contraindications for the use of corticosteroids as premedication

• No preexisting grade 2 or greater peripheral neuropathy

• No active uncontrolled infection

• No uncontrolled diabetes mellitus

• No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix

• No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent

• No other serious underlying medical condition that would preclude study participation

• No socioeconomic or geographical circumstances that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)

Radiotherapy:

• No prior radiotherapy to the chest

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since prior treatment in a clinical trial

• No prior cytostatic therapy

• No other concurrent experimental drugs