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

NCT ID: NCT00321334

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetexel

Chemotherapy+Surgery

Group Type: ACTIVE_COMPARATOR

Chemotherapy+Surgery

Intervention Type: PROCEDURE

Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles

Interventions

Chemotherapy+Surgery

Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Society of Lung Cancer

OTHER

Sponsor Role: lead

Responsible Party

Yi-Long Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-Long Wu, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Chinese Society of Lung Cancer

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CSLC0501

Identifier Type: -

Identifier Source: org_study_id