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Clinical Trials/EUCTR2010-023081-52-GB
EUCTR2010-023081-52-GB
Active, not recruiting
Phase 1

A phase II 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 sites240 target enrollmentMay 23, 2013
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Danish Gynaecological Cancer Group
Enrollment
240
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 23, 2013
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

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, 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\.aPatients 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.

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.

Outcomes

Primary Outcomes

Not specified

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