The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
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ClinicalTrials.gov Identifier: NCT00162721 |
Recruitment Status : Unknown
Verified August 2007 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : September 13, 2005
Last Update Posted : August 10, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Sarcoma | Drug: doxorubicin, ifosfamide, cisplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 270 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas |
Study Start Date : | September 2001 |

- 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
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162721
Contact: Patricia Pautier, Dr | 33 1 42 11 4340 | pautier@igr.fr | |
Contact: Annie Rey | 33 1 42 11 4137 | rey@igr.fr |
France | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94800 | |
Contact: Patricia Pautier, Dr 33 1 42 11 4340 pautier@igr.fr |
Principal Investigator: | Patricia Pautier, Dr | Gustave Roussy, Cancer Campus, Grand Paris |
ClinicalTrials.gov Identifier: | NCT00162721 |
Other Study ID Numbers: |
SARC-GYN1 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | August 10, 2007 |
Last Verified: | August 2007 |
Uterine sarcoma non metastatic |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Ifosfamide Antineoplastic Agents |
Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |