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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132639

Enrollment

Registered

2005-08-22

Start date

2002-10-31

Completion date

2008-11-30

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Neoplasms

Keywords

pulmonary neoplasm, preoperative chemotherapy, cisplatin, docetaxel, randomized trial, clinical stage IB or II nonsmall cell lung cancer

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.

Interventions

DRUGPreoperative docetaxel-cisplatin combination chemotherapy

Preoperative docetaxel-cisplatin combination chemotherapy

DRUGPreoperative docetaxel monotherapy

Preoperative docetaxel monotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame
disease-free survival rate at 1 year	during the study conduct

Secondary

Measure	Time frame
disease-free survival	during the study conduct
treatment compliance	during the study conduct
response rate to chemotherapy	during the study conduct
overall survival	during the study conduct
complete resection rate	during the study conduct
post-surgical morbidity/mortality	during the study conduct
pathologic complete response (CR) rate	during the study conduct

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026