Clinical trial NCT00132639: Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Neoplasms
Keywords: pulmonary neoplasm
preoperative chemotherapy
cisplatin, docetaxel
randomized trial
clinical stage IB or II nonsmall cell lung cancer
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-08-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: disease-free survival rate at 1 year
timeFrame: during the study conduct
Secondary outcomes:
measure: overall survival
timeFrame: during the study conduct
measure: disease-free survival
timeFrame: during the study conduct
measure: treatment compliance
timeFrame: during the study conduct
measure: response rate to chemotherapy
timeFrame: during the study conduct
measure: pathologic complete response (CR) rate
timeFrame: during the study conduct
measure: complete resection rate
timeFrame: during the study conduct
measure: post-surgical morbidity/mortality
timeFrame: during the study conduct
Other outcomes:
Locations:
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center
state: Tokyo
Study officials:
affiliation: Tokyo Medical University
name: Harubumi Kato, MD, PhD
role: STUDY_CHAIR
References: