Chemotherapy and Radiation Therapy Compared With Radiation Therapy Alone in Treating Patients With High-Risk Stage I, Stage II, or Stage III Endometrial Cancer

Official Title

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

Summary:

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.

Trial Description

Primary Outcome Measures:

• Overall survival at 5 years
• Failure-free survival at 5 years

Secondary Outcome Measures:

• Quality of life by QLQ-C30 v3.0
• Severe treatment-related morbidity
• Rate of vaginal or pelvic relapse
• Rate of distant metastases

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 radiation therapy 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 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.

• Arm I: Patients receive cisplatin IV over 1-2 hours on days 1 and 22 and external-beam pelvic radiation therapy 5 days a week for up to 6 weeks. At least 3 weeks after completion of chemoradiotherapy, patients undergo adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour 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 radiation therapy as in arm I. In both arms, patients with cervical involvement undergo vaginal brachytherapy.

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