NL-OMON41312RecruitingPhase 3
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. - EORTC55102; Adjuvant chemotherapy for high risk endometrial cancer
Danish Gynecological Cancer Group0 sites12 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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
Investigators
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