Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.

Sponsor:

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Information provided by:

Japan Clinical Oncology Group

ClinicalTrials.gov Identifier:

NCT00132639

First received: August 19, 2005

Last updated: February 2, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2005

Last Updated Date

February 2, 2009

Start Date ^ICMJE

October 2002

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

disease-free survival rate at 1 year [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

disease-free survival rate at 1 year

Change History

Complete list of historical versions of study NCT00132639 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

overall survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
disease-free survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
treatment compliance [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
response rate to chemotherapy [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
pathologic complete response (CR) rate [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
complete resection rate [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
post-surgical morbidity/mortality [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

overall survival
disease-free survival
treatment compliance
response rate to chemotherapy
pathologic CR rate
complete resection rate
post-surgical morbidity/mortality

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (NSCLC)

Official Title ^ICMJE

Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.

Detailed Description

Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different in earlier stages. There have been no prospective randomized trials to choose an optimal preoperative chemotherapy in early stage NSCLC.

Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in clinical stage IB/II NSCLC.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Neoplasms

Intervention ^ICMJE

Drug: Preoperative docetaxel-cisplatin combination chemotherapy
Preoperative docetaxel-cisplatin combination chemotherapy
Drug: Preoperative docetaxel monotherapy
Preoperative docetaxel monotherapy

Study Arm (s)

Experimental: 1
Preoperative docetaxel-cisplatin combination chemotherapy

Intervention: Drug: Preoperative docetaxel-cisplatin combination chemotherapy
Active Comparator: 2
Preoperative docetaxel monotherapy

Intervention: Drug: Preoperative docetaxel monotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Newly diagnosed, pathologically documented NSCLC
Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
Ages: 15-74 years old
ECOG performance status 0 or 1
Measurable disease
Ample organ function
Signed informed consent

Exclusion Criteria:

Invasion to the first rib or more superior chest wall
Metastasis to, or involvement of, mediastinal node
Active concomitant malignancy
Unstable angina, recent myocardial infarction, or heart failure
Uncontrolled diabetes or hypertension
Pregnant or lactating women
Other severe complications
Systemic use of corticosteroids

Gender

Both

Ages

20 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00132639

Other Study ID Numbers ^ICMJE

JCOG 0204-MF, C000000032

Has Data Monitoring Committee

Yes

Responsible Party

Japan Clinical Oncology Group

Study Sponsor ^ICMJE

Japan Clinical Oncology Group

Collaborators ^ICMJE

Ministry of Health, Labour and Welfare, Japan

Investigators ^ICMJE

Study Chair:

Harubumi Kato, MD, PhD

Tokyo Medical University

Information Provided By

Japan Clinical Oncology Group

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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