NCT00004253

Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel
RADIATION	radiation therapy

Timeline

• Start date: 2000-03-01
• First posted: 2003-07-23
• Last updated: 2013-12-18

Locations

2 sites across 1 country: United States