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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162721

Enrollment

270

Registered

2005-09-13

Start date

2001-09-30

Completion date

Unknown

Last updated

2007-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Sarcoma

Keywords

Uterine sarcoma non metastatic

Brief summary

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.

Interventions

DRUGdoxorubicin, ifosfamide, cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival	—
Evaluation of global toxicity of the treatment in each arm	—

Countries

France

Contacts

Primary ContactPatricia Pautier, Dr

pautier@igr.fr33 1 42 11 4340

Backup ContactAnnie Rey

rey@igr.fr33 1 42 11 4137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026