Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma
Description
Design:
PORTEC-3 is a prospective, multicentre, randomised Phase III intergroup trial led by the Dutch Cooperative Gynaecologic Oncology Group, in collaboration with the UK National Cancer Research Institute, NCIC-CTG, ANZGOG, MaNGO Group and UNICANCER (FEDEGYN Group).
Treatment:
Patients in the standard arm will be treated with pelvic radiotherapy and brachytherapy boost in case of cervical involvement. Patients in the experimental arm will be treated with the same radiotherapy schedule and 2 cycles of cisplatin given concurrently with radiotherapy at a 21-day interval. The first concurrent cycle is to be given within days 1 to 3 of radiotherapy and the second cycle 3 weeks after the first cycle. After completion of radiotherapy, patients will receive 4 additional cycles of adjuvant chemotherapy: carboplatin and paclitaxel at 21-day intervals.
Key inclusion/exclusion criteria:
Patients with endometrial carcinoma staged 1 and is at high risk of relapsed or is stage 2 or 3, had TAH-BSO surgery, WHO-PS 0 to 2, satisfactory blood results. Patients should not have sarcoma, radiotherapy to the pelvis before, hormone treatment or chemotherapy for the endometrial carcinoma, any residual macroscopic tumour after surgery, peripheral neuropathy grade 2 or above, hearing impairment grade 3 or above.
Duration of recruitment:
The actual recruitment was 4 years and ended December 2013.
Aim
The aim of the study is to establish overall survival and failure-free survival of patient with high-risk and advanced stage endometrial carcinoma, treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone.