Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer

• Status: Active, not recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Australia New Zealand Gynaecological Oncology Group; Cancer Research UK; Mario Negri Institute for Pharmacological Research; NCIC Clinical Trials Group; UNICANCER
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:

1. stage IA with invasion, grade 3 with documented LVSI

2. stage IB grade 3

3. stage II

4. stage IIIA or IIIC; or IIIB if parametrial invasion only

5. stage IA (with invasion), IB, II, or III with serous or clear cell histology

• WHO-performance status 0-2

• WBC ≥ 3.0 x 109/L.

• Platelets ≥ 100 x 109/L.

• Bilirubin ≤ 1.5 x UNL

• ASAT/ALAT ≤ 2.5 x UNL

• Written informed consent

Exclusion criteria:

• Uterine sarcoma (including carcinosarcoma)

• Previous malignancy (except for non-melanomatous skin cancer) < 10 yrs

• Previous pelvic radiotherapy

• Hormonal therapy or chemotherapy for this tumor

• Macroscopic stage II for which Wertheim type hysterectomy (eligible if stage II grade 3 or stage III at pathology)

• Prior diagnosis of Crohn's disease or ulcerative colitis

• Residual macroscopic tumor after surgery

• Creatinine clearance ≤ 60 ml/min (Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance)

• Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy

• Peripheral Neuropathy > or = grade 2

• Hearing impairment > or = grade 3, or born deaf