A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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 < 2 x upper normal value, ALAT < 2.5 x upper normal value, estimated GFR >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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is to evaluate the overall survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are disease specific survival, progression-free survival,<br /><br>rates of isolated pelvic (central or pelvic wall), distant and mix relapses,<br /><br>quality of life, compliance and toxicity.</p><br>