Clinical trial · Interventional
Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer
A Randomized, Open Label, Single Centre Clinical Trial of Pelvic External Radiotherapy Combined With 252-Cf Neutron Intracavitary Brachytherapy With or Without Platinum in Treatment of Local Advanced Cervical Cancer
NCT02835404CI-TRIAL-00023106unknownPhase 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 objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.
Conditions
Conditions (2)
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 |
| Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 252-Cf Neutron Intracavitary Brachytherapy | Radiation | — | UNRESOLVED |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
| Pelvic External Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concurrent radiochemotherapy Group
- description
- Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
- interventionNames
- Drug: Nedaplatin
- Radiation: Pelvic External Radiotherapy
- Radiation: 252-Cf Neutron Intracavitary Brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy Group
- description
- patients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. To be aged from 18 (including 18) to 65 (including 65), female patient; * 2\. Expected survival ≥6 months * 3\. Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB; * 4\. No patients with distant metastases; * 5\. Measurable target lesions (satisfying the criteria in RECIST 1.1); * 6\. ECOG PS status of 0-2; * 7\. No prior treatment; * 8\. No * 9\. No surgery * 10\. Major organ function has to meet the following criteria: 1. Bilirubin \<1.5 times the upper limit of normal (ULN) 2. ALT , AST and APL≤2.5 × ULN 3. NEUT≥2.0 × 10\^9 / L 4. PLT ≥ 100 × 10\^9 / L 5. HB≥60g/L 6. Serum Cr and urea nitrogen ≤ 1.5 × ULN * 11\. Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled. Exclusion Criteria: * 1\. Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance; * 2\. Allergic to platinum; * 3\. Rejecte to join the study in other conditions.
References
Publications (0)
Data not yet available
No reference posted for this study.