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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulmonary Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Preoperative docetaxel-cisplatin combination chemotherapy

Group Type EXPERIMENTAL

Preoperative docetaxel-cisplatin combination chemotherapy

Intervention Type DRUG

Preoperative docetaxel-cisplatin combination chemotherapy

2

Preoperative docetaxel monotherapy

Group Type ACTIVE_COMPARATOR

Preoperative docetaxel monotherapy

Intervention Type DRUG

Preoperative docetaxel monotherapy

Interventions

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Preoperative docetaxel-cisplatin combination chemotherapy

Intervention Type DRUG

Preoperative docetaxel monotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No