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

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00132639

Purpose

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.

Condition	Intervention	Phase
Pulmonary Neoplasms	Drug: Preoperative docetaxel-cisplatin combination chemotherapy Drug: Preoperative docetaxel monotherapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	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)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

disease-free survival rate at 1 year

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	October 2002
Estimated Study Completion Date:	November 2008

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.

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132639

Locations

Japan, Tokyo
National Cancer Center
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Harubumi Kato, MD, PhD

Tokyo Medical University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	JCOG 0204-MF, C000000032
Study First Received:	August 19, 2005
Last Updated:	March 5, 2007
ClinicalTrials.gov Identifier:	NCT00132639
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

pulmonary neoplasm
preoperative chemotherapy
cisplatin, docetaxel
randomized trial
clinical stage IB or II nonsmall cell lung cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009