Not Signed In -
Docetaxel |
Taxotere |
Clinical Trial: Randomized Phase II Study of Preoperative Docetaxel or CDDP+Docetaxel for c-Stage IB-II NSCLC(JCOG0204-MF)
This study is no longer recruiting patients.
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Pulmonary Neoplasm | Drug: Preoperative docetaxel-cisplatin combination chemotherapy Drug: Preoperative docetaxel monotherapy | Phase II |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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)
Secondary Outcomes: overall survival; disease-free survival; treatment compliance; response rate to chemotherapy; pathologic CR rate; complete resection rate; post-surgical morbidity/mortality
Expected Total Enrollment: 80
Study start: October 2002; Study completion: December 2008
Last follow-up: December 2008; Data entry closure: December 2008
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
Inclusion Criteria:
- Newly diagnosed, pathologically documented NSCLC
- Clinical stage, IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
- Age: 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, heart failure
- Uncontrolled diabetes or hypertension
- Pregnant or lactating women
- Other severe complications
- Systemic use of corticosteroid
Location Information
Harubumi Kato, MD, PhD, Study Chair, Tokyo Medical University
More Information
http://www.jcog.jp/
Last Updated: August 19, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00132639
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
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