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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
06/04/2009
Funder:
Cancer Research UK
Sponsor:
Leiden University Medical Centre (LUMC)
Chief Investigator:
Dr Melanie Powell (UK) and Dr Carien Creutzberg (Netherlands)
Recruitment target:
670
EudraCT number:
2007-004917-33
Contact details:
ctc.PORTEC-3@ucl.ac.uk
Lay summary:
PORTEC-3
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.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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