Endometrial cancer MedDRA version: 21.0 Level: PT Classification code 10014738 Term: Endometrial cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10014739 Term: Endometrial cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: paclitaxel
Pharmaceutical Form:
INN or Proposed INN: paclitaxel
INN or Proposed INN: carboplatin
Product Name: Carboplatin
Pharmaceutical Form:
Sponsors
Danish Gynaecological Cancer Group (DGCG)
Eligibility
Sex/Gender
All
Inclusion 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.a Patients 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. 5. Surgery performed within 12 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 12 weeks are counted from the last sur-gery, and in that case the gap between two surgeries should not exceed 8 weeks. Other inclusion criteria 6. Patients must give informed consent according to the rules and regulations of the individual participating centres. 7. Patients have not received any other anticancer therapy other than surgery for en-dometrial cancer. 8. Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery. 9. Patients must have a WHO performance status of 0-2 10. 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 50 ml/min (measured or calculated according to Cockroft-Gault, Jeliffe or Wright formula). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated. 11. Life expectancy of at least 12 weeks. 12. Patients must be fit to receive combination chemotherapy. 13. 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 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
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. 8. Whatever reasons which interferes with an adequate follow-up 9. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival (OS) of patients treated with adjuvant chemotherapy or to observation. Patients with medium and high-risk stage I and II endometrial cancers have, despite radical surgery, a rather high risk for progression. This is performed by comparing overall survival in the subgroup of endometrioid adenocarcinoma. If this is positive whole population is evaluated. Combination chemotherapy regimen of paclitaxel-carboplatin is proposed in this study, as this combination is effective and well tolerated. The eligible patients for such a study are a fraction of patients with endometrial cancer there-fore this study will be performed within the ENGOT collaboration.;Secondary Objective: •Overall survival of whole study population. •Descriptive analysis of overall survival in non-endometrioid adenocarcinoma. •Disease Specific Survival (DSS) •Progression-Free Survival (PFS) •Toxicity (both acute and late) •Compliance •Quality of Life (QOL) and symptom control will be assessed using EORTC QLQ-C30 and EORTC-QLQ-EN24 •Rate of isolated pelvic relapse (central or pelvic wall) •Rate of isolated distant relapse •Rate of mix local and distant relapse ;Primary end point(s): overall survival in the subgroup of endometrioid adenocarcinoma;Timepoint(s) of evaluation of this end point: Events driven timepoint Number of events needed 38 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival of whole study population. • Descriptive analysis of overall survival in non-endometrioid adenocarcinoma. • Disease Specific Survival (DSS) • Progression-Free Survival (PFS) • Toxicity (both acute and late) • Compliance • Quality of Life (QOL) and symptom control will be assessed using EORTC QLQ-C30 and EORTC-QLQ-EN24 • Rate of isolated pelvic relapse (central or pelvic wall) • Rate of isolated distant relapse • Rate of mix local and distant relapse ;Timepoint(s) of evaluation of this end point: at the time when OS is reached Events driven timepoint Number of events needed 57 | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactMansoor Raza Mirza
Danish Gynaecological Cancer Group (DGCG)
Outcome results
None listed