Clinical trial · Interventional
Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
NCT01756170CI-TRIAL-00021951unknownPhase 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)
This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.
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
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Patients receive radiotherapy alone as in arm 1.
- interventionNames
- Radiation: Radiotherapy
- 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.
- interventionNames
- Drug: paclitaxel
- Drug: cisplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- disease-free survival
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 (non-small cell type) * Negative lymph node * At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve 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
References
Publications (0)
Data not yet available
No reference posted for this study.