Clinical trial · Interventional
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
NCT00162721CI-TRIAL-00000832unknownPhase 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 is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.
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 |
|---|---|---|---|
| Uterine Sarcoma | Uterine Corpus Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin, ifosfamide, cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas
Secondary outcomes (2)
- measure
- Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
- measure
- Evaluation of global toxicity of the treatment in each arm
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed uterine sarcoma (rereading in reference centers) * Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma * All stages \<= stage III (FIGO modified for endometrial carcinoma) * Full surgical exeresis * Age \>= 18 years and physiological age \<= 65 years * Negative extension check-up (thoracic and abdomino-pelvic TDM) * Performance status (PS) \<= 2 (ECOG) * Normal haematologic functions (absolute neutrophil count \> 1,500/mm3, platelets \> 100,000/mm3) * Serum creatinine \< 1.25 x ULN * Good hepatic check-up (total serum bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN) * Absence of neuropathy \> grade 1 * Left ventricular ejection fraction \> 50% (by isotopic or ultrasound scan determination) * Written informed consent Exclusion Criteria: * Low grade endometrial stromal sarcoma * Time since surgery \> 8 weeks * Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones) * Antecedents or evolutive psychiatric disorder * Concurrent active infection or other serious uncontrolled systemic disease * Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix
References
Publications (0)
Data not yet available
No reference posted for this study.