Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BHM-L1 BHM-99-64, NCI-V99-1582, NCT00004253

Objectives

1. 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).
2. Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients.
3. Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines.
4. Determine the feasibility of patient-specific dose escalation using this regimen in these patients.
5. Determine the quality of life and symptom distress in these patients on this regimen.

Entry 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

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

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

Expected Enrollment

A total of 26-72 patients will be accrued for this study within 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Baptist-South Miami Regional Cancer Program

Andre Abitbol, MD, Protocol chair		Ph: 786-596-6566; 800-599-2456 Email: andrea@baptisthealth.net

Registry 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
Trial Start Date		2000-03-01
Registered in ClinicalTrials.gov		NCT00004253
Date Submitted to PDQ		1999-12-30
Information Last Verified		2002-11-01

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