Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: Chemotherapy+Surgery

• Registration Number: NCT00321334
• Lead Sponsor: Chinese Society of Lung Cancer

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetexel	Chemotherapy+Surgery	Chemotherapy+Surgery

Primary Outcome Measures

Name	Time	Method
3 years Disease Free Survival (at end of 3 years)	Prospective

Secondary Outcome Measures

Name	Time	Method
3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)	Prospective

Trial Locations

Locations (1)

Chinese Society of Lung Cancer; 🇨🇳 Guangzhou, Guangdong, China