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

Haruhiko Fukuda

Status and phase: Completed; Phase 2

Conditions: Pulmonary Neoplasms

Treatments: Drug: Preoperative docetaxel-cisplatin combination chemotherapy; Drug: Preoperative docetaxel monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00132639

C000000032

JCOG 0204-MF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

Preoperative docetaxel-cisplatin combination chemotherapy

Treatment:

Drug: Preoperative docetaxel-cisplatin combination chemotherapy

2

Active Comparator group

Description:

Preoperative docetaxel monotherapy

Treatment:

Drug: Preoperative docetaxel monotherapy