Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed
worldwide. Surgical resection offers the best chance for cure for those patients diagnosed
with early-stage disease, however, the vast majority of patients experience eventually
relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage
NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to
improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB
9633, JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete
resection will prolong survival. On the other hand, Depierre et al had conducted a trial to
demonstrate preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve
survival. We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy
to answer which treatment model is better to early stager NSCLC. Based on proven activity
and survival benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant
therapy, even as a potential option in adjuvant setting.
Comparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to
complete resection for NSCLC.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3 years Disease Free Survival (at end of 3 years)
Prospective
Yes
Yi-Long Wu, MD, FACS
Principal Investigator
Guangdong General Hospital
China: Food and Drug Administration
CSLC0501
NCT00321334
March 2006
December 2013
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