A Phase III Randomised Trial of Gemcitabine plus Docetaxel followed by Doxorubicin versus observation for uterus-limited, high grade uterine leiomyosarcoma
- Conditions
- Patients with high risk uterine LMS, FIGO stage I (confined to corpus +/- cervix).MedDRA version: 14.1 Level: PT Classification code 10046799 Term: Uterine leiomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002852-17-GB
- Lead Sponsor
- EORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 216
- Patients with high risk uterine leiomyosarcoma (LMS), FIGO stage 1 (confined to corpus +/- cervix.) Patient with known uterine serosa involvement are not eligible. Patient should have had, at least, a complete hysterectomy (including removal of the cervix). Bilateral salpingo-oophorectomy is not required. - Institutional pathology review calls the uterine leiomyosarcoma high grade - Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high power field. - All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment to the study. If a patient requires a second operation to complete her surgery i.e. trachelectomy to remove the cervix and/or BSO, the 12 weeks may be counted from the time of the second operation. - All patients must have no evidence of persistent or metastatic disease as documented by a post resection CT of the chest/abdomen/pelvis or by CT chest + MRI abdomen/pelvis. The post resection imaging studies should be performed within 4 weeks of registration of the study. - Patients must have adequate bone marrow function, renal function, hepatic function and neurologic function as defined by study protocol. - ECOG performance status of 0 or 1 - Patient have met pre-entry requirements specified in section 7 of study protocol - Patient is > or = 18 years of age - Patient has given written informed consent - Patient should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
-Patients who have had prior therapy with docetaxel or gemcitabine or doxorubicin at any time in their history - Patients with a history of other invasive malignancies, with exception of non-melanoma skin cancer, are ineligible if there is any evidence of other non malignancy being present within the last five years. Patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy. - Patients with a history of severe hypersensitivity reaction to taxotere(docetaxel) or other drugs formulated with polysorbate 80. - Patients with ECOG performance status 2,3 or 4 - Patients who are breast feeding - Patients with a known history of congestive heart failure or cardiac ejection <50% (or less than institutional normal limits) ECHO or MUGA is not required prior to enrollment. For patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within 6 months of starting treatment. - Patients with a history of prior whole pelvic radiation - Concurrent treatment with HRT is permitted at the discretion of treating physician. Patients who have been taking hormonal/hormone blocking agents for breast cancer or breast cancer prevention or other indication are eligible. - Patients with recurrent uterine LMS - Patients who are know to be HIV positive are not eligible due to the high risk for infectious complications of the myelosuppresive therapy used in the experimental arm of this study. - Patients with gross residual or metastatic tumour findings following complete surgical treatment for uterine LMS
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method