Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: gemcitabine; Radiation: radiation; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00192036

8984

B9E-BX-JHSQ (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inoperable non small cell lung cancer Stage III
• Adequate hematological parameters
• Adequate Lung function reserve

Exclusion criteria

• Previous chemotherapy and thoracic radiation for non small cell lung cancer
• Presence of distant metastases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Gemcitabine + Cisplatin

Experimental group

Description:

Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.

Treatment:

Radiation: radiation

Drug: cisplatin

Drug: gemcitabine