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Completed

NCT Number: NCT00132639

Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)

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.

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Key information

Conditions

Pulmonary Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center

Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative docetaxel-cisplatin combination chemotherapy

Drug

Preoperative docetaxel-cisplatin combination chemotherapy

Preoperative docetaxel monotherapy

Drug

Preoperative docetaxel monotherapy

Primary outcomes

  1. disease-free survival rate at 1 year

    Time frame: during the study conduct

Secondary outcomes

  1. overall survival

    Time frame: during the study conduct

  2. disease-free survival

    Time frame: during the study conduct

  3. treatment compliance

    Time frame: during the study conduct

  4. response rate to chemotherapy

    Time frame: during the study conduct

  5. pathologic complete response (CR) rate

    Time frame: during the study conduct

  6. complete resection rate

    Time frame: during the study conduct

  7. post-surgical morbidity/mortality

    Time frame: during the study conduct

Sponsors and collaborators

Lead sponsor

Haruhiko Fukuda

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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