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Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer

Phase 3
18 Years
75 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 years Disease Free Survival (at end of 3 years)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Yi-Long Wu, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital


China: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • Chemotherapy
  • surgery
  • neo-adjuvant
  • adjuvant
  • RCT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms