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 drug with either standard radiation therapy or radiation therapy given at different times may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation therapy given at different times, in treating patients with stage III non-small cell lung cancer that cannot be surgically removed.

Condition	Treatment or Intervention	Phase
stage IIIB non-small cell lung cancer stage IIIA non-small cell lung cancer Squamous Cell Lung Cancer Adenocarcinoma of the Lung large cell lung cancer	Drug: carboplatin  Drug: paclitaxel	Phase III

Further Study Details: 

OBJECTIVES: I. Determine response rates, duration of response, and survival of patients with unresectable or regionally advanced (M0) stage IIIA or IIIB non-small cell lung carcinoma treated with induction paclitaxel and carboplatin followed by conventional vs accelerated radiation. II. Evaluate the patterns of local and distant failure for patients treated with these regimens.

PROTOCOL OUTLINE: Patients are stratified by histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and response to induction chemotherapy (initial response vs no response). All patients receive induction therapy consisting of paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats every 42 days for 2 courses. Patients whose disease has not progressed outside the thorax are then randomized to 1 of 2 treatment arms. Arm I: Patients receive standard radiotherapy once a day, 5 days a week for 6-7 weeks. Arm II: Patients receive hyperfractionated accelerated radiotherapy 3 times daily, 5 days a week over 2.5 weeks. Each fraction is separated by a minimum of 4 hours. Radiotherapy begins between days 43 and 50. Patients are followed at 1 month after radiotherapy, then every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: Approximately 294 patients will be accrued for this study within 3.5 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed unresectable stage IIIA or IIIB non-small cell carcinoma of the lung; Adenocarcinoma; Squamous cell carcinoma; Anaplastic large cell carcinoma
• Stage IIIA patients must not be candidates for resection after neoadjuvant therapy (unresectable T3N1 or T1-3 primary tumors with metastasis limited to the ipsilateral mediastinal and subcarinal lymph nodes); Mediastinotomy or thoracoscopy required for potentially resectable IIIa disease when ipsilateral mediastinal lymph nodes are less than 2 cm
• Stage IIIB patients must not have significant pleural effusion (seen on CT scan only OR does not reaccumulate after one thoracentesis and is cytologically negative); Metastases to contralateral mediastinal or supraclavicular nodes allowed
• Measurable or evaluable disease
• No distant metastasis or significant pleural effusion

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior systemic chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior thoracic radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: At least 12 weeks
• Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3; Hemoglobin at least 10 g/dL
• Hepatic: Bilirubin less than 1.5 mg/dL; SGOT no greater than 2 times normal; No liver disease with significant hepatic insufficiency
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min
• Cardiovascular: No cardiac arrhythmia or end stage congestive heart failure
• Neurologic: No preexisting clinically significant peripheral neuropathy; No organic brain syndrome
• Other: No history of prior or concurrent malignancy in the past 5 years except: Surgically cured basal cell carcinoma of the skin; Carcinoma in situ of the cervix; Not pregnant; Fertile patients must use effective contraception during and for 2 weeks after study

New Jersey
      Community Medical Center, Toms River,  New Jersey,  08755,  United States
      Overlook Hospital, Summit,  New Jersey,  07902-0220,  United States
      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States
      Trinitas Hospital - Jersey Street Campus, Elizabeth,  New Jersey,  07201,  United States
Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States

Study chairs or principal investigators

Chandra Prakash Belani,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000066107; E-2597; CTSU
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003235
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08