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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014