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Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy

ConditionCervical Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorThe Central and Eastern European Gynecologic Oncology Group

About this trial

The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a 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%).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed invasive cervical cancer

FIGO IB1-IIA

Squamous cell cancer or HPV-related adenocarcinoma

tumour ≥4 cm OR

Disqualifiers

Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)

Inconclusive primary site of disease

Unequivocally positive lymph node by imaging (by radiological subjective assessment)

FIGO <IB1 / >IIA

Trial design

Design model

Parallel

Treatments tested in this trial

  • No adjuvant therapy

    Radiation

    Patients will not receive any type of adjuvant therapy.

  • Adjuvant radiotherapy

    Radiation

    Patients will receive adjuvant treatment composed of either pelvic radiotherapy external beam radiotherapy ± brachytherapy or concomitant chemoradiotherapy (pelvic radiotherapy + chemotherapy).

Treatment groups

514 Participants
are divided into 2 treatment groups
Group A: A: Surgery onlyExperimental treatment 1 intervention
Group B: B: Surgery + radiothrerapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival

Calculated as an interval from the day of randomisation until diagnosis of recurrence: (a) unequivocal finding on imaging by subjective radiological assessment; b) suspicious recurrence on imaging either confirmed by biopsy or supported by other signs (disease progression on imaging or progression of symptoms); (c) physical examination supported by clinical evidence (i.e., symptoms or progression); or (d) death caused by disease or death of unknown cause.

Time frame
Analysed 3 years after randomization of the last patient.

Secondary outcomes

1

Overall survival

Time frame
Analysed 6 years after randomization of the last patient.
2

Pelvic disease-free survival

Time frame
Analysed 3 years after randomization of the last patient.
3

Health-related quality of life based questionnaire

The analysis will be made based on EORTC validated questionnaires and developed qualitative CERVANTES questionnaire.

Time frame
Analysed 3 years after randomization of the last patient.
4

Treatment-related adverse events based on Common Terminology Criteria for Adverse Events v5.0

Time frame
Analysed 3 years after randomization of the last patient.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Central and Eastern European Gynecologic Oncology Group

Lead sponsor

General University Hospital, Prague

Sponsor institution

Source ClinicalTrials.gov
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