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.

Phase 1

• Conditions: ode-negative stage I-II intermediate or high risk endometrial cancer; MedDRA version: 21.0Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10014739Term: Endometrial cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023081-52-BE
• Lead Sponsor: Danish Gynaecological Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

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. Active infection or other serious underlying medical condition, which
might prevent the patient from receiving treatment or to be followed.
8. Whatever reasons which interferes with an adequate follow-up
9. 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