Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Patients with stage 1 & 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown survival benefit in more advanced stage disease (stage 3 & 4).

This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).

Substudy: Translational research

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Gynecological Cancer Group
• Collaborators: Arbeitsgemeinschaft Gynaekologische Onkologie Austria; Belgian Gynaecological Oncology Group; Central and Eastern European Oncology Group; European Organisation for Research and Treatment of Cancer - EORTC; Israeli Society of Gynecologic Oncology; Mario Negri Gynecologic Oncology group (MaNGO); Mario Negri Gynecologic Oncology group (MaNGO) Italy; Mayo Clinic; Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITTO); Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO) Germany; Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit; North Eastern German Society of Gynaecological Oncology
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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:

1. Stage I grade 3 endometrioid adenocarcinoma

2. Stage II endometrioid adenocarcinoma

3. Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, or undifferentiated carcinoma) Prior therapy

2. Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy (LNE).

3. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional

4. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma.

5. Surgery performed within 10 weeks of randomization. If the dates for hysterectomy 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.

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.

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 <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.

11. Life expectancy of at least 12 weeks

12. Patients must be fit to receive combination chemotherapy

13. Patient's age >18 years

Exclusion criteria:

Target Disease Exceptions

1. Carcinosarcoma, 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 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. Whatever reasons which interferes with an adequate follow-up