An international randomised trial of radical surgery followed by adjuvant therapy versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CERVANTES)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CEEGOG z.s.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 Sep 2023 → ongoing

Decision date (initial)

2026-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-504973-19-01

ClinicalTrials.gov

NCT04989647

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objective of the trial is to evaluate if adjuvant therapy is associated with disease-free survival benefit after radical surgery in patients with intermediate-risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).

Conditions and MedDRA coding

early-stage, intermediate-risk cervical cancer

Study design 1 period

Regulatory references

Plan to share IPD

Yes

IPD plan description

All participant data collected in this clinical trial will be pseudonymized to protect individual privacy. Each participant will be identified solely by an assigned identification number specific to this trial, ensuring that no personal identifiers leave the clinician's workplace. All information that could enable patient identification will be treated as confidential and stored securely, in compliance with applicable local legislation. Access to participant data will be strictly limited to authorized personnel and representatives involved in the project, who require access to perform designated tasks and fulfill project responsibilities. This limited access is designed to uphold data confidentiality and protect participant privacy throughout the trial and any subsequent data-sharing processes. Details on the patients´ data management and protection are in the protocol section 17 „DATA MANAGEMENT AND MONITORING

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Patient recently (<4 weeks) underwent surgery composed of radical hysterectomy and LN staging based on the standards recommended by this protocol. 2. Pathologically confirmed invasive cervical cancer 3. FIGO IB2–IIA 4. Squamous cell cancer or HPV related adenocarcinoma 5. Age 18–85 years 6. Presence of pathologically confirmed tumour-related risk factors as follows: • tumour ≥4 cm OR • tumour >2 cm <4 cm AND lymphovascular space invasion OR • tumour >2 cm <4 cm AND tumour free distance <3 mm OR • tumour >2 cm <4 cm AND deep stromal invasion (>2/3) 7. Negative pelvic lymph nodes and no evidence of distant metastases (based on final pathology) 8. ECOG performance status 0–1 9. Deemed suitable and fit for adjuvant external beam radiotherapy (after radical surgery) 10. Negative HIV test (performed in high-risk countries or patients who have moved from those countries within the past 10 years)

Exclusion criteria 1

1. 1. Adenosquamous cancer or adenocarcinoma unusual type (HPV unrelated – such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria) 2. Inconclusive primary site of disease 3. Positive pelvic lymph nodes (by preoperative imaging or confirmed pathologically) 4. FIGO IIA 5. Previous pelvic malignancy 6. History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR) 7. Previous pelvic radiotherapy 8. Neoadjuvant chemotherapy prior to surgical treatment 9. Low likelihood of patient compliance to the follow-up 10. Immunosuppressive medication if it cannot be terminated for the trial duration 11. Lactating patients not willing to stop before the trial treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-free survival [ Time Frame: Analysed 3 years after randomization of the last patient. ]

Secondary endpoints 1

1. 1. Overall survival. 2.Pelvic disease-free survival. 3. Health-related quality of life based questionnaire. 4. Treatment-related adverse events based on Common Terminology Criteria for Adverse Events v5.0.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CEEGOG z.s.

Sponsor organisation

CEEGOG z.s.

Address

Na Folimance 2155/15, Vinohrady Vinohrady

City

Prague 2

Postcode

120 00

Country

Czechia

Scientific contact point

Organisation

CEEGOG z.s.

Contact name

Clinical trial information desk

Public contact point

Organisation

CEEGOG z.s.

Contact name

Clinical trial information desk

Locations

6 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications