Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy With Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3
Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumour cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumour cells. Giving chemotherapy and radiation therapy after surgery may kill any tumour 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.
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.
Primary Outcome Measures:
Secondary Outcome Measures:
OUTLINE: This is a multicentre, prospective, open-label, randomized, controlled study. Patients are stratified according to participating group (Dutch Cooperative Gynecologic Oncology Group vs United Kingdom National Cancer Research Institute), type of surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy [TAH-BSO] vs TAH-BSO plus lymphadenectomy vs laparoscopically-assisted vaginal hysterectomy), stage (IB vs IC vs II vs III), and histological type (endometrioid carcinoma vs serous or clear cell carcinoma). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, completion of radiation therapy, 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.
Reviewed by OCREB
View this trial on ClinicalTrials.gov
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