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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Andre A. Abitbol, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Baptist Health South Florida
Authority:
United States: Federal Government
Study ID:
CDR0000067500
NCT ID:
NCT00004253
Start Date:
March 2000
Completion Date:
Related Keywords:
- Lung Cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
