Status:
COMPLETED
A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Locally Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 st...
Detailed Description
Lung cancer is the most common malignancy among men in most countries and constitutes the leading cause of cancer death worldwide. Non-small cell histology represents roughly 80% of lung cancer cases ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03371550
Start Date
August 5 2004
End Date
October 31 2011
Last Update
December 13 2017
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