A phase 3 trial evaluating efficacy of postoperative chemotherapy in high-risk early stage endometrial cancer

• Conditions: Endometrial cancer; MedDRA version: 16.1Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: 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-SE
• Lead Sponsor: Danish Gynaecological Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 678

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, or squamous cell carci-noma, or undifferentiated carcinoma)
Prior therapy
1.2.Patients have undergone hysterectomy (total abdominal hysterectomyTAH, radical hysterectomy, laparoscopic or robotic hysterectomy) and & bilateral salpingo-oopherectomy (BSO) (or RH) and+ pelvic lymphadenectomy (LNE) within the past 10 weeks.
2.3.LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional
4.Omentectomy strongly recommended in type 2 disease (clear cell, serous, squamous cell carcinoma or undifferentiated carcinoma)
3.5.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.
Other inclusion criteria
1.6.Patients must give informed consent according to the rules and regulations of the individual participating centres
2.7.Patients have not received any other anticancer therapy other than surgery.
3.8.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. be administered at the end of chemotherapy in the chemo-therapy arm
4.9.Patients must have a WHO performance status of 0-2
5.10.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 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.
6.11.Life expectancy of at least 12 weeks
7.12.Patients must be fit to receive combination chemotherapy
8.13.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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Target Disease Exceptions
•1.Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differen-tiation.
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 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 the whole trial period, otherwise these patients are non-eligible

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified