Informations générales (source: ClinicalTrials.gov)
Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
septembre 2001
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Patricia Pautier, Dr | Contact (sur clinicalTrials) | |||
Critères
Femme
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
- 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
- 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