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

August 4, 2014 updated by: Yi-Long Wu, Chinese Society of Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Chinese Society of Lung Cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetexel
Chemotherapy+Surgery
Procedure: Chemotherapy+Surgery
Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 years Disease Free Survival (at end of 3 years)
Time Frame: Prospective
Prospective

Secondary Outcome Measures

Outcome Measure
Time Frame
3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)
Time Frame: Prospective
Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Society of Lung Cancer

Investigators

  • Principal Investigator: Yi-Long Wu, MD, FACS, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSLC0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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