NL-OMON41312
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. - EORTC55102; Adjuvant chemotherapy for high risk endometrial cancer
Danish Gynecological Cancer Group0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- endometrial cancer
- Sponsor
- Danish Gynecological Cancer Group
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 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).;b. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para\-aortic LNE is optional;c. Omentectomy strongly recommended in 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. ;3\. Other inclusion criteria;a. Patients must give informed consent according to the rules and regulations of the individual participating centres;b. Patients have not received any other anticancer therapy other than surgery.;c. Adjuvant vaginal brachytherapy permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery. ;d. Patients must have WHO performance status of 0\-2 ;e. Patients must have an adequate bone\-marrow, renal and hepatic function (WBC \>\=3\.0x109/L, neutrophils \>\=1\.5x109/L, platelets \>\=100x109/L, total S\-bilirubin \< 2 x upper normal value, ALAT \< 2\.5 x upper normal value, estimated GFR \>50 ml/min (measured or calculated according to Cockroft\-Gault or Jeliffe). Up to 5% deviation for hematological values and 10% deviation for s\-bilirubin and ALAT are tolerated.;f. Life expectancy of at least 12 weeks;g. Patients must be fit to receive combination chemotherapy;h. Patient\*s age \> 18 years
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
- •Patients who are breast feeding must stop breast feeding
- •before enrolment in the trial and must not do so during the whole trial period, otherwise these patients are non\-eligible
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
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
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
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