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
- 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
- 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
- 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
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
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.
Primary Purpose: Treatment
Andre A. Abitbol, MD
Baptist Health South Florida
United States: Federal Government
|Sylvester Cancer Center, University of Miami
|Miami, Florida 33136
|Baptist Hospital of Miami
|Miami, Florida 33176-2197