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
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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