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

This study is currently recruiting participants.
Verified January 2012 by Chinese Society of Lung Cancer
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT00321334
First received: May 1, 2006
Last updated: January 15, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Procedure: Chemotherapy+Surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Chinese Society of Lung Cancer:

Primary Outcome Measures:
  • 3 years Disease Free Survival (at end of 3 years) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 410
Study Start Date: March 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Chemotherapy+Surgery
    Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321334

Contacts
Contact: Yi-Long WU, MD,FACS +8620,83877855 syylwu@live.cn

Locations
China, Guangdong
Chinese Society of Lung Cancer Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xiao-song Ben, MD     +862083877855     benxs@163.com    
Principal Investigator: Yi-Long WU, MD, FACS            
Sponsors and Collaborators
Chinese Society of Lung Cancer
Investigators
Principal Investigator: Yi-Long Wu, MD, FACS Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Yi-Long Wu, Professor, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT00321334     History of Changes
Other Study ID Numbers: CSLC0501
Study First Received: May 1, 2006
Last Updated: January 15, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Society of Lung Cancer:
non-small cell lung cancer
Chemotherapy
surgery
 neo-adjuvant
adjuvant
RCT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Adjuvants, Immunologic
Docetaxel
Carboplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013