Clinical trial · Interventional
Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
NCT01755845CI-TRIAL-00021949unknownPhase 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)
The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage 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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: paclitaxel
- Drug: cisplatin
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Patients receive chemoradiotherapy as in arm 1.
- interventionNames
- Drug: paclitaxel
- Drug: cisplatin
- Radiation: radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type) * One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement) * Eastern Cooperative Oncology Group 0-2 * Expected life span over 6 months. * No distant metastasis * Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl) * Adequate renal functions(serum creatinine ≤ 1.5mg/dl) * Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value) * Written informed consent Exclusion Criteria: * Previous history of chemotherapy or radiation * Hypersensitive reaction to platinum/paclitaxel agent * History of other cancer * Concurrent systemic illness not appropriate for chemotherapy * Active infection requiring antibiotics * Pregnancy * Metastasis to paraaortic lymph node
References
Publications (0)
Data not yet available
No reference posted for this study.