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Clinical Trials/EUCTR2010-023081-52-BE
EUCTR2010-023081-52-BE
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 enrollmentSeptember 24, 2012
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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/mlCARBOPLATIN 10 mg/ml

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
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 24, 2012
End Date
TBD
Last Updated
2 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, squamous cell
  • •carcinoma, carcinosarcoma or undifferentiated carcinoma)
  • •Prior therapy

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
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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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: 20.0Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: 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-ATDanish Gynaecological Cancer Group240
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A phase trial evaluating efficacy of postoperative chemotherapy in high-risk early stage endometrial cancerEndometrial 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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Not Applicable
Postoperative chemotherapy or no treatment in endometrial cancerEndometrial 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]
EUCTR2010-023081-52-FIDanish Gynaecological Cancer Group678