EUCTR2010-023081-52-PT
Active, not recruiting
Not Applicable
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. - ENGOT-EN2-DGCG
Danish Gynaecological Cancer Group0 sites678 target enrollmentMarch 25, 2013
Conditionsode-negative stage I-II intermediate or high risk endometrial cancerMedDRA version: 15.1Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ode-negative stage I-II intermediate or high risk endometrial cancer
- Sponsor
- Danish Gynaecological Cancer Group
- Enrollment
- 678
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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) 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.
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
Outcomes
Primary Outcomes
Not specified
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