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 EMA (CTIS).
22.8.2024 Ethics committee approved amended protocol v2.0 in General University Hospital in Prague, Czech Republic. Other sites promptly followed:
i. Penta Hospital Bratislava Bory (SK)
ii. Faculty Hospital Trencin (SK)
iii. Faculty Hospital Ostrava (CZ)
iv. Hospital Ceske Budejovice (CZ)
v. Dr Panait Sarbu Hospital/Memorial Hospital, Bucharest, Romania and Sanador Oncology Center (RO)
vi. Mexico's National Cancer Institute (MX)
vii.Chongqing University Cancer Hospital (CHN)
40 patients from 8 recruiting centres in 7 countries
17 centres in initiation phase from 11 countries
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