CERVical cancer: AdjuvaNt ThErapy and radical Surgery

CERVATES clinical trial

An international randomised trial of radical surgery followed by adjuvant therapy versus no further

treatment in patients with early-stage, intermediate-risk cervical cancer

Trial News

I. The CERVANTES team prepared protocol amendment (version v2.0) which should speed up patient enrolment, eliminate patients drop out and set mandatory adjuvant treatment. The two main changes include:

A. Registration of patients into the study only after surgery: this approach allows for more precise selection of suitable candidates for the study as all inclusion criteria are known based on the final histological examination. This increases the overall validity of the results obtained and eliminates patients drop out.
B. Establishment of a minimum standard for adjuvant treatment - external pelvic radiotherapy (EBRT): that is internationally recognised standard for adjuvant treatment in these patients; this adjustment ensures that all patients included in the study receive appropriate and consistent treatment in accordance with current guidelines. Moreover, this also means that Cervantes is no longer a pharmacological trial and appropriate approval of such a trial lies in hands of Institutional Review Boards (IRBs).

This protocol was approved by our local ethics committee and is now under assessment of EMA via CTIS.

II. Let’s get together!

The CERVANTES team is attending the ESGO 2025 conference in Rome and prepared a meeting where we would like to introduce the protocol amendment and provide current status update. So if you would like to get in touch with us, are interested in joining our important study or have any questions, please pop in ESGO meeting room 1 on the Mezzanine floor on Friday 21.2.2025 between 13:10-13:40.

All news here

22.8.2024 Ethics committee approved amended protocol v2.0 in General University Hospital in Prague, Czech republic. Four more sites promptly followed:

i. Nemocnica Bory Bratislava, Slovakia

ii. FN Trencin, Slovakia

iii. FN Ostrava, Czech republic

iv. Hospital Ceske Budejovice, Czech republic

v. Dr Panait Sarbu Hospital/Memorial Hospital, Bucharest, Romania and Sanador Oncology Center