Non-small Cell Lung Cancer Clinical Trial
Official title:
Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer
Verified date | August 2014 |
Source | Chinese Society of Lung Cancer |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin) after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC.
Status | Completed |
Enrollment | 410 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy; - age from 18 to 75; - PS with ECOC 0-1; - Adequate haematological and Hepatic- renal function; - Expected to live longer than 12 months; - The informed consent should be signed. Exclusion Criteria: - Patients with Small Cell Lung Cancer; - Already receiving any prior anti-cancer treatment; - Pregnant women; - Uncontrolled diabetes, mental disease; - Hepatic and renal function failure; - The investigators believe the patient is not suitable to be enrolled in the study |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chinese Society of Lung Cancer | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Chinese Society of Lung Cancer |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 years Disease Free Survival (at end of 3 years) | Prospective | Yes | |
Secondary | 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish) | Prospective | Yes |
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