Protocol Title:

A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer.

Protocol Status:

Closed

Protocol Number:

R 0239

Type of Cancer:

Lung cancer (limited small cell)

Principal Investigator :

David Ettinger, MD

Research Nurse:

Shirl DiPasquale, RN

Phase Number:

II

General Eligibility:

Confirmed small cell carcinoma of the lung is required. Patients must have limited disease (clinical stages I-IIIb, i.e., confined to one hemithorax, but excluding T4 tumor based on malignant pleural effusion or N3 disease based on contralateral hilar or contralateral supraclavicular involvement). Patients must have measurable or evaluable disease. Age = 18; Zubrod Performance Scale 0-1. Adequate hematologic, hepatic, and renal function as follows: absolute granulocytes = 1500; platelets = 150,000; bilirubin = 1.5 mg/dl; and serum creatinine = 1.5 mg/dl are required. Radiation oncologist must certify that tumor can be encompassed by limited radiotherapy fields without significantly compromising pulmonary function.
Patients of childbearing potential (male and female) must practice adequate contraception. Patients must be available
for active follow up. Patients must sign a study-specific consent form prior to study entry.

Purpose:

Primary:
• Determine overall survival in patients with limited small cell lung cancer treated with cisplatin and oral etoposide and combined with concurrent higher dose of thoracic radiotherapy (TRT) followed by etoposide and cisplatin.
Secondary:
• Determine the toxicity and reversibility of toxicity of daily TRT followed by hyperfractionated TRT as a boost.
• Determine the response rates and progression-free survival

Treatment:

Radiation Therapy
Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions.
On days 23-26, treatment 2 times a day : use AP/PA fields in AM @ 1.8 Gy per fraction; boost with 2nd treatment in PM @ 1.8 Gy per fraction; then off-cord boost, 1.8 Gy, 2 times a day, for the last 5 days for a total dose of 61.2 Gy in 5 weeks

Concurrent Chemotherapy
Chemotherapy will be started on day 1 of thoracic radiotherapy (± 24 hours)
Cisplatin, 60 mg/m2 i.v. day 1; etoposide, 120 mg/m2 i.v. day 1; etoposide, 240 mg/m2 p.o. per day
on days 2 and 3 or etoposide 120 mg/m2 i.v. per day on days 2 or 3 (see Section 7.1.4);