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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:
ClinicalTrials.gov Identifier:
NCT00132639
First Posted: August 22, 2005
Last Update Posted: September 22, 2016
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.
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Haruhiko Fukuda, Japan Clinical Oncology Group:

Primary Outcome Measures:
  • disease-free survival rate at 1 year [ Time Frame: during the study conduct ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: during the study conduct ]
  • disease-free survival [ Time Frame: during the study conduct ]
  • treatment compliance [ Time Frame: during the study conduct ]
  • response rate to chemotherapy [ Time Frame: during the study conduct ]
  • pathologic complete response (CR) rate [ Time Frame: during the study conduct ]
  • complete resection rate [ Time Frame: during the study conduct ]
  • post-surgical morbidity/mortality [ Time Frame: during the study conduct ]

Enrollment: 80
Study Start Date: October 2002
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Preoperative docetaxel-cisplatin combination chemotherapy
Drug: Preoperative docetaxel-cisplatin combination chemotherapy
Preoperative docetaxel-cisplatin combination chemotherapy
Active Comparator: 2
Preoperative docetaxel monotherapy
Drug: Preoperative docetaxel monotherapy
Preoperative docetaxel monotherapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00132639


Locations
Japan
National Cancer Center
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Harubumi Kato, MD, PhD Tokyo Medical University
  More Information

Additional Information:
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00132639     History of Changes
Other Study ID Numbers: JCOG 0204-MF
C000000032
First Submitted: August 19, 2005
First Posted: August 22, 2005
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
pulmonary neoplasm
preoperative chemotherapy
cisplatin, docetaxel
randomized trial
clinical stage IB or II nonsmall cell lung cancer

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
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action