NCT00321334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

7.8 years

First QC Date

May 1, 2006

Last Update Submit

August 4, 2014

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancerChemotherapysurgeryneo-adjuvantadjuvantRCT

Outcome Measures

Primary Outcomes (1)

  • 3 years Disease Free Survival (at end of 3 years)

    Prospective

Secondary Outcomes (1)

  • 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)

    Prospective

Study Arms (1)

Docetexel

ACTIVE COMPARATOR

Chemotherapy+Surgery

Procedure: Chemotherapy+Surgery

Interventions

Chemotherapy+SurgeryPROCEDURE

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

Docetexel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Society of Lung Cancer

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yi-Long Wu, MD, FACS

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

CN(1)