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Clinical Trials/EUCTR2010-023081-52-DE
EUCTR2010-023081-52-DE
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 enrollmentJuly 5, 2013
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Conditionsode-negative stage I-II intermediate or high risk endometrial cancerMedDRA 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]
DrugsPACLITAXEL 6mg/ml Concentrate For Solution For InfusionCARBOPLATIN 10 mg/ml Intravenous Infusion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
ode-negative stage I-II intermediate or high risk endometrial cancer
Sponsor
Danish Gynaecological Cancer Group
Enrollment
240
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 5, 2013
End Date
TBD
Last Updated
last year
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 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 carcinoma, or undifferentiated carcinoma)
  • •Patients with prior therapy:
  • •2\. 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)
  • •3\. LNE: minimum 10 pelvic nodes (a minimum of 4 from each side) should be removed. Para\-aortic LNE is optional
  • •3a. Patients who undergo sentinel lymph node biopsy (SLB) may be included if the surgeon performing the SLB for endometrial 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 identified in a hemi\-pelvis.
  • •4\. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma

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 anotheranticancer clinical trial
  • •Other exclusion criteria
  • •5\. Previous or concurrent malignant disease except for patients with second malignanx 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. 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 whole trial period, otherwise these patients are non\-eligible

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
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.ode-negative stage I-II intermediate or high risk endometrial cancerMedDRA 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]
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