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)

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) - 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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000032

Enrollment

Registered

2005-07-28

Start date

2002-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

pulmonary neoplasm

Interventions

Preoperative docetaxel-cisplatin combination chemotherapy Preoperative docetaxel monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Newly diagnosed, pathologically documented NSCLC (2)Clinical stage, IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0) (3)Age: 15-74 years old (4)ECOG performance status 0 or 1 (5)Measurable disease (6)Ample organ function (7)Signed informed consent

Exclusion criteria

Exclusion criteria: (1) Invasion to the first rib or more superior chest wall (2) Metastasis to, or involvement of, mediastinal node (3) Active concomitant malignancy (4)Unstable angina, recent myocardial infarction, heart failure (5)Uncontrolled diabetes or hypertension (6) Pregnant or lactating women (7)Other severe complications (8)Systemic use of corticosteroid

Design outcomes

Primary

Measure	Time frame
Disease-free survival rate at 1 year	—

Secondary

Measure	Time frame
overall survical, disease-free survival, treatment compliance, response rate to chemotherapy, pathologic CR rate, complete resection rate, post-surgical morbidity/mortality	—

Countries

Japan

Contacts

Public ContactHideo Kunitoh, M.D.

JCOG0204 Coordinating Office Department of Respiratory Medicine, Mitsui Memorial Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026