endometrial cancer uterine cancer
Conditions
Interventions
Patients are randomized to one of the two treatment arms
1:1 randomization (chemotherapy vs. observation):
• Arm I: Patients receive postoperative adjuvant intravenous paclitaxel and
intravenous carb
chemotherapy
endometrial carcinoma
intermediate and high risk
lymph node negative
Sponsors
Danish Gynecological Cancer Group
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Target Population;1.Only node-negative patients are eligible: Histological confirmed endometrial carcinoma with no macroscopic remaining tumour after primary surgery and lymph-node negative disease, with one of the following postoperative FIGO 2009 stage and grade:;a.Stage I grade 3 endometrioid adenocarcinoma;b.Stage II endometrioid adenocarcinoma;c.Stage I and II type 2 histology (clear cell, serous, or squamous cell carci-noma, or undifferentiated carcinoma);2. Patients with prior therapy: ;a. Patients have undergone hysterectomy (total abdominal hysterectomy (TAH), radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oopherectomy (BSO) (or RH) and+ pelvic lymphadenectomy (LNE).;b. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional;c. Omentectomy strongly recommended in clear cell, serous, squamous cell carcinoma or undifferentiated carcinoma;d. Surgery performed within 10 weeks of randomization. If the dates for hys-terectomy and lymph node dissection are different, 10 weeks are counted from the last surgery, and in that case the gap between two surgeries should not exceed 8 weeks. ;3. Other inclusion criteria;a. Patients must give informed consent according to the rules and regulations of the individual participating centres;b. Patients have not received any other anticancer therapy other than surgery.;c. Adjuvant vaginal brachytherapy permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery. ;d. Patients must have WHO performance status of 0-2 ;e. Patients must have an adequate bone-marrow, renal and hepatic function (WBC >=3.0x109/L, neutrophils >=1.5x109/L, platelets >=100x109/L, total S-bilirubin 50 ml/min (measured or calculated according to Cockroft-Gault or Jeliffe). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.;f. Life expectancy of at least 12 weeks;g. Patients must be fit to receive combination chemotherapy;h. Patient*s age > 18 years
Exclusion criteria
Exclusion criteria: 1. Target disease exclusions:;•Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differen-tiation. ;2. Prohibited Treatments and/or Therapies;•External Beam Radiotherapy;•Concurrent cancer therapy;•Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial;3. Other exclusion criteria;•Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin;•Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed;•Whatever reasons which interferes with an adequate follow-up Patients who are breast feeding must stop breast feeding before enrolment in the trial and must not do so during the whole trial period, otherwise these patients are non-eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to evaluate the overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are disease specific survival, progression-free survival, rates of isolated pelvic (central or pelvic wall), distant and mix relapses, quality of life, compliance and toxicity. | — |
Countries
The Netherlands
Outcome results
None listed