NCT00411138

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

Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy With Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 670 (estimated)
• Sponsor: Leiden University · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Compare the overall survival and failure-free survival of patients with high-risk stage IB-III endometrial carcinoma treated with concurrent chemoradiotherapy followed by adjuvant chemotherapy vs pelvic radiotherapy alone. Secondary * Compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life of patients treated with these regimens. OUTLINE: This is a multicenter, prospective, open-label, randomized, controlled study. Patients are stratified according to participating group (DGOG vs UK NCRI vs NCIC CTG vs MaNGO vs Unicancer), type of surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy \[TAH-BSO\] vs TAH-BSO plus lymphadenectomy vs laparoscopic hysterectomy \[TLH-BSO\] vs TLH-BSO plus lymphadenectomy), stage (IA vs IB vs II vs III), and histological type (endometrioid carcinoma vs serous or clear cell carcinoma). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive external-beam pelvic radiotherapy 5 days a week for up to 6 weeks, combined with cisplatin IV days 1 and 22. Patients with cervical involvement undergo vaginal brachytherapy boost. At least 3 weeks after completion of chemoradiotherapy, patients undergo adjuvant chemotherapy comprising paclitaxel IV and carboplatin IV on day 1. Adjuvant chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo external-beam pelvic radiotherapy (and vaginal brachytherapy alone in case of cervical involvement) as in arm I. Quality of life is assessed at baseline, completion of radiotherapy, completion of chemotherapy, at 6 months, and then once a year for 5 years. After completion of study therapy, patients are followed periodically for up to 10 years. PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
DRUG	cisplatin	cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
DRUG	carboplatin	carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
DRUG	Paclitaxel	paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval

Timeline

• Start date: 2006-11-23
• Primary completion: 2018-11-29
• Completion: 2024-12-31
• First posted: 2006-12-13
• Last updated: 2023-10-11

Locations

1 site across 1 country: Netherlands