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

Pulmonary Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132639
• Other study ID #: JCOG 0204-MF
• Secondary ID: C000000032
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2005
• Last updated: September 20, 2016
• Start date: October 2002
• Est. completion date: November 2008

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Pulmonary Neoplasms

Intervention

Drug:
• Preoperative docetaxel-cisplatin combination chemotherapy
Preoperative docetaxel-cisplatin combination chemotherapy
• Preoperative docetaxel monotherapy
Preoperative docetaxel monotherapy

Locations

Country	Name	City	State
Japan	National Cancer Center	Chuo-ku,Tsukiji,5-1-1	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival rate at 1 year		during the study conduct	No
Secondary	overall survival		during the study conduct	No
Secondary	disease-free survival		during the study conduct	No
Secondary	treatment compliance		during the study conduct	No
Secondary	response rate to chemotherapy		during the study conduct	No
Secondary	pathologic complete response (CR) rate		during the study conduct	No
Secondary	complete resection rate		during the study conduct	No
Secondary	post-surgical morbidity/mortality		during the study conduct	Yes

External Links

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