A phase II clinical trial for patients with node-negative stage I-II intermediate or high risk endometrial cancer where the patients will be divided into 2 groups; chemotherapy after surgery versus observation only.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 240

Inclusion Criteria

Target Population
1. Only node-negative patients are eligible: Histological confirmed endometrial carci-noma 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, squamous cell carcinoma, carcinosarcoma or undifferentiated carcinoma)
Prior therapy
2. Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oopherectomy (BSO) and pelvic lymphadenectomy (LNE).
3. LNE: minimum 10 pelvic nodes (4 from each side) should be removed. Para-aortic LNE is optional.
3.a Patients who undergo sentinel lymph node biopsy (SLB) may be included if the surgeon performing the SLB has performed at least 20 cases of SLB for endome-trial cancer. In addition, for each patient, bilateral sentinel node must be identified or a side-specific pelvic lymphadenectomy must be performed if a SLN is not iden-tified in a hemi-pelvis.
4. Omentectomy strongly recommended in clear cell, serous or undifferentiated car-cinoma.
5. Surgery performed within 12 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 12 weeks are counted from the last sur-gery, and in that case the gap between two surgeries should not exceed 8 weeks.
Other inclusion criteria
6. Patients must give informed consent according to the rules and regulations of the individual participating centres.
7. Patients have not received any other anticancer therapy other than surgery for en-dometrial cancer.
8. Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery.
9. Patients must have a WHO performance status of 0-2
10. 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 up-per normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or calculated according to Cockroft-Gault, Jeliffe or Wright formula). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.
11. Life expectancy of at least 12 weeks.
12. Patients must be fit to receive combination chemotherapy.
13. Patient’s age >18 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Target Disease Exceptions
1. Sarcomas or small cell carcinoma with neuroendocrine differentiation.
Prohibited Treatments and/or Therapies
2. External Beam Radiotherapy.
3. Concurrent cancer therapy.
4. Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial.
Other exclusion criteria
5. Previous or concurrent malignant disease except for patients with second malig-nancy who has been relapse free for =3 years, or patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
6. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
7. Whatever reasons which interferes with an adequate follow-up
8. Patients who are breast feeding must stop breast feeding before enrolment in the trial and must not do so during whole trial period, otherwise these patients are non-eligible.

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

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