None listed
Conditions
Brief summary
This is a trial of follow-up (adjuvant) treatment with combined chemotherapy and radiation treatment followed by further chemotherapy for women who have undergone surgery for endometrial carcinoma but are thought to be at high-risk of developing relapse of the cancer
Interventions
Adjuvant chemo-radiation followed by chemotherapy. Patients will be treated with adjuvant pelvic radiotherapy plus concurrent Carboplatin chemotherapy, followed by 4 cycles of chemotherapy with Carboplatin plus Paclitaxel. The toal duration of the intervention is 24 weeks.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have newly diagnosed, histologically confirmed endometrial carcinoma, and have undergone a total abdominal hysterectomy and bilateral salpingo-oophorectomy with or without a dissection of pelvic and/or para-aortic nodes. It is also recommended that patients will have undergone an omentectomy and had peritoneal washings taken. In addition, patients must be either:A. Patients with documented involvement of pelvic and/or para-aortic nodes by histology (FIGO stage IIIc) or post-operative PET, CT or PET/CTORB. Patients who have not undergone a complete lymphadenectomy, who have negative sampled nodes or unknown nodal status and have high-risk disease as defined by:a) FIGO stage Ic or IIb with : aggressive non-endometroid histology (serous papillary or clear cell type comprising 10% of the endometrial tumour) ORb) FIGO stage IIb with : grade 3 histologyc) Any FIGO stage III disease excluding those defined as stage III only by positive peritoneal cytologyPatients must not have received any prior chemotherapy for another malignancy. Patients who have been treated for other malignancies must not have received prior pelvic or abdominal radiotherapy, and any prior radiotherapy must have been to less than 15% of the bone marrow bearing areasECOG performance status less than 2Life expectancy of greater than 6 months.Patients must have normal organ and marrow function as defined below:- absolute neutrophil count >1,500- platelets > 100,000- total bilirubin < 1.25 X upper limit of normal - AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal.- estimated GFR > 50 ml/minPatient has given written informed consent.
Exclusion criteria
Patients with other invasive malignancies, with the exception of treated non-melanoma skin cancer, in the last 5 yearsPatients receiving any other therapeutic investigational agents Patients who are receiving concurrent treatment with any other anti-cancer therapyPatients who have commenced any post-surgical anti-cancer treatment for endometrial cancerEvidence of distant metastasesHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin Symptomatic peripheral neuropathy greater than or equal to grade 2.Serious illness of medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Outcome results
None listed