Clinical trial · Interventional
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)
NCT00132639CI-TRIAL-00023984completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative docetaxel-cisplatin combination chemotherapy | Drug | — | UNRESOLVED |
| Preoperative docetaxel monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Preoperative docetaxel-cisplatin combination chemotherapy
- interventionNames
- Drug: Preoperative docetaxel-cisplatin combination chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Preoperative docetaxel monotherapy
- interventionNames
- Drug: Preoperative docetaxel monotherapy
Primary outcomes (1)
- measure
- disease-free survival rate at 1 year
- timeFrame
- during the study conduct
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.