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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00321334
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Procedure: Chemotherapy+Surgery Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2006
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 3 years Disease Free Survival (at end of 3 years) [ Time Frame: Prospective ]

Secondary Outcome Measures :
  1. 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish) [ Time Frame: Prospective ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321334


Locations
China, Guangdong
Chinese Society of Lung Cancer
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Chinese Society of Lung Cancer
Investigators
Principal Investigator: Yi-Long Wu, MD, FACS Guangdong General Hospital
More Information

Responsible Party: Yi-Long Wu, Professor, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT00321334     History of Changes
Other Study ID Numbers: CSLC0501
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action