Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2010-023081-52-FI
EUCTR2010-023081-52-FI
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 enrollmentJanuary 8, 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsEndometrial cancerMedDRA version: 18.1Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: 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
Endometrial cancer
Sponsor
Danish Gynaecological Cancer Group
Enrollment
678
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 8, 2013
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Danish Gynaecological Cancer Group

Eligibility Criteria

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.

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
  • •0\.5\.Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • •1\.6\.Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed
  • •2\.7\.Whatever reasons which interferes with an adequate follow\-up

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
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.ode-negative stage I-II intermediate or high risk endometrial cancerMedDRA version: 18.0Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: 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]
EUCTR2010-023081-52-NLDanish Gynaecological Cancer Group678
Active, not recruiting
Not Applicable
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.ode-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]
EUCTR2010-023081-52-PTDanish Gynaecological Cancer Group678
Active, not recruiting
Not Applicable
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.ode-negative stage I-II intermediate or high risk endometrial cancerMedDRA version: 16.0Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: 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]
EUCTR2010-023081-52-ESDanish Gynaecological Cancer Group678
Recruiting
Phase 3
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.endometrial canceruterine cancer10038594
NL-OMON41312Danish Gynecological Cancer Group12
Active, not recruiting
Not Applicable
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.ode-negative stage I-II intermediate or high risk endometrial cancerMedDRA version: 17.0Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: 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]
EUCTR2010-023081-52-ITDanish Gynaecological Cancer Group678