A phase III 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: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 678

Inclusion Criteria

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) within the past 10 weeks.
b. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional
c. Omentectomy strongly recommended in type 2 disease (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 is not recommended, though permitted in both arms. In chemotherapy arm, VBT 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 > or = 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 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

Target Disease Exceptions
1. Carcinosarcoma, 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 anotheranticancer clinical trial
Other exclusion criteria
5. Previous or concurrent malignant disease except for 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

Related Trials

Postoperative chemotherapy or no treatment in endometrial cancer

Danish Gynaecological Cancer Group

Updated 2/1/2016