Clinical trial · Interventional
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Bulky Stage I/II Cervical Cancer: Japan Clinical Oncology Group Trial (JCOG0102)
NCT00190528CI-TRIAL-00023977terminatedPhase 3ClinicalTrials.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)
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer
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 |
|---|---|---|---|
| Cervical Neoplasms | Cervical Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemotherapy + radical hysterectomy | Drug | — | UNRESOLVED |
| radical hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- interventionNames
- Procedure: radical hysterectomy
- type
- EXPERIMENTAL
- label
- Chemotherapy + Surgery
- interventionNames
- Drug: neoadjuvant chemotherapy + radical hysterectomy
Primary outcomes (1)
- measure
- overall survival
Secondary outcomes (7)
- measure
- progression-free survival
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Untreated cervical cancer 2. Pathologically diagnosed squamous carcinoma 3. FIGO stage Ib2, IIa (\>4cm), and IIb 4. Measurable lesions 5. Possible to radical hysterectomy 6. Age: 20 to 70 years 7. PS: 0 and 1 8. WBC \> 3,000/mm3, Hb \> 9.0g/dl, Platelet \> 100,000 /mm3, SGOT/SGPT \< 60 IU/L, T-Bil \< 1.5 mg/dL, Cr \< 1.2 mg/dL, PaO2 \> 80 torr, normal ECG 9. Written informed consent Exclusion Criteria: 1. Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer those are curable with local therapy 2. Women during pregnancy or breast-feeding 3. Patients with psychiatric illness 4. Patients who have active infection 5. Patients who have uncontrolled diabetes or uncontrolled hypertension 6. Patients who have positive HBs 7. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 8. Patients with interstitial pneumonitis or pulmonary fibrosis 9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
References
Publications (0)
Data not yet available
No reference posted for this study.