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.
- Conditions
- 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]
- Registration Number
- EUCTR2010-023081-52-PT
- Lead Sponsor
- Danish Gynaecological Cancer Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 678
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) within the past 10 weeks.
b. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional
c. Omentectomy strongly recommended in type 2 disease (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 is not recommended, though permitted in both arms. In chemotherapy arm, VBT 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare overall survival (OS) of patients treated with adjuvant chemotherapy or to observation.<br><br>Patients with medium and high-risk stage I and II endometrial cancers have, despite radical surgery, a rather high risk for progression. <br><br>Combination chemotherapy regimen of paclitaxel-carboplatin is proposed in this study, as this combination is effective and well tolerated.<br>;Secondary Objective: •Disease Specific Survival (DSS)<br>•Progression-Free Survival (PFS)<br>•Toxicity (both acute and late)<br>•Compliance<br>•Quality of Life (QOL) and symptom control will be assessed using EORTC QLQ-C30 and EORTC-QLQ-EN34<br>•Rate of isolated pelvic relapse<br>•Rate of isolated distant relapse<br>•Rate of mix local and distant relapse<br>;Primary end point(s): The primary endpoint of this trial is overall survival.;Timepoint(s) of evaluation of this end point: Survival is calculated from the date of randomization until the date of death.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Disease Specific Survival (DSS)<br>• Progression-Free Survival (PFS)<br>• Toxicity (both acute and late)<br>• Compliance<br>• Quality of Life (QOL) <br>• Rate of isolated pelvic relapse (central or pelvic wall)<br>• Rate of isolated distant relapse<br>• Rate of mix local and distant relapse;Timepoint(s) of evaluation of this end point: Survival is calculated from the date of randomization until the date of death.<br>The DSS is calculated from the date of randomization until the date of death caused by cancer, Patients who die of non-disease-related causes are censored at time of death.<br>The PFS is calculated as time elapsed from date of randomization to date of progression or death of disease, whichever is the first registered event. Vaginal, pelvic and distant relapses will be registered.<br>QoL will be registered during whole study period.<br>Toxicity will be graded according to the Common Terminology for Adverse Events (CTCAE v4.0)