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

August 19, 2005
February 2, 2009
October 2002
November 2008   (final data collection date for primary outcome measure)
disease-free survival rate at 1 year [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
disease-free survival rate at 1 year
Complete list of historical versions of study NCT00132639 on ClinicalTrials.gov Archive Site
  • 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 ]
  • overall survival
  • disease-free survival
  • treatment compliance
  • response rate to chemotherapy
  • pathologic CR rate
  • complete resection rate
  • post-surgical morbidity/mortality
Not Provided
Not Provided
 
Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
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)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Neoplasms
  • Drug: Preoperative docetaxel-cisplatin combination chemotherapy
    Preoperative docetaxel-cisplatin combination chemotherapy
  • Drug: Preoperative docetaxel monotherapy
    Preoperative docetaxel monotherapy
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00132639
JCOG 0204-MF, C000000032
Yes
Japan Clinical Oncology Group
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Harubumi Kato, MD, PhD Tokyo Medical University
Japan Clinical Oncology Group
February 2009

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