This trial is active, not recruiting.

Condition lung cancer
Treatments carboplatin, paclitaxel, radiation therapy
Phase phase 2
Sponsor Baptist Health South Florida
Start date March 2000
Trial identifier NCT00004253, BHM-99-64, BHM-L1, CDR0000067500, NCI-V99-1582


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Patients with unresected locally advanced non-small cell lung cancer - Stage II, IIIA, or IIIB - No evidence of hematogenous metastases - No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) - No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 2,000/mm3 - Platelet count at least 130,000/mm3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No active or symptomatic cardiac disease - No acute myocardial infarction within the past 6 months - No angina - No congestive heart failure - No uncontrolled arrhythmias - Cardiac ejection fraction greater than 50% Pulmonary: - FEV1 at least 1.25 L AND - DLCO at least 50% predicted Other: - Not pregnant - Fertile patients must use effective contraception - Weight loss no greater than 5% within 3 months of diagnosis - No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior thoracic or neck radiotherapy Surgery: - See Disease Characteristics

Additional Information

Official title A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin
Description OBJECTIVES: - Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT). - Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients. - Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines. - Determine the feasibility of patient-specific dose escalation using this regimen in these patients. - Determine the quality of life and symptom distress in these patients on this regimen. OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT). Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks. Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels. Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months. Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).