A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy

• Status: Completed
• Trial end date: 2011-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced stage III non-small cell lung cancer. However, the optimal combination remains unclear. The aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and 22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5 fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate. Secondary objectives are toxicity, time to progression, and overall survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Antoine Lacassagne
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed NSCLC,

• stage IIIB (excluding malignant pleural or pericardial effusions, tumoral volume exceeding one radiation field,

• N3 supraclavicular, and contralateral hilar nodal involvement) or inoperable stage IIIA defined by the new International Staging System [21],

• 18 ≤ age ≤ 75 years,

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2,

• weight loss <10%,

• at least one measurable lesion according to RECIST 1.0 criteria,

• adequate hematopoietic function (absolute neutrophil count ≥2 × 109/l, platelets ≥100 × 109/l, and hemoglobin level ≥10g/dl), adequate hepatic function [total serum bilirubin less than or equal to the institutional upper limit of normal (ULN), aspartate aminotransferase ≤1.5× ULN, and alkaline phosphatase ≤5× ULN], and adequate renal function (serum creatinine ≤1.5× ULN).

Exclusion Criteria:

• patients previously treated with radiotherapy or chemotherapy for NSCLC,

• previous cancer except basocellular carcinoma and in situ carcinoma of the cervix curatively treated and other cancers curatively treated for at least 5 years,

• peripheral neuropathy NCI-CTC grade ≥2,

• noncontroled severe disease,

• pregnant or breast-feeding women.