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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Japan Clinical Oncology Group:

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

Secondary Outcome Measures:
  • 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 ]

Estimated 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

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

Additional Information:
No publications provided

Responsible Party: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00132639     History of Changes
Other Study ID Numbers: JCOG 0204-MF, C000000032
Study First Received: August 19, 2005
Last Updated: February 2, 2009
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

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014