A Phase 3 interventional study of No adjuvant therapy and Adjuvant radiotherapy in Cervical Cancer, sponsored by The Central and Eastern European Gynecologic Oncology Group. Recruiting at 1 site in Czechia. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by The Central and Eastern European Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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%).
The role of adjuvant (chemo)radiotherapy in intermediate risk (IR) cervical cancer patients is controversial, supported by single randomised GOG 92 study performed more than 20 years ago. Intermediate-risk group is defined as lymph node negative but with a combination of negative prognostic factors (tumour size >2 cm, lymphovascular space invasion, deep stromal invasion >2/3). Recent retrospective studies showed excellent local control in intermediate risk group patients after radical surgery with no additional adjuvant treatment.
CERVANTES trial is designed to bring level A evidence on the role of adjuvant treatment in IR patients in an international, prospective, randomised study. Patients will be registered into the trial before surgery and randomised after the final pathology report has been received into ARM A, with no additional treatment, and ARM B, receiving adjuvant (chemo)radiotherapy. Quality assurance program will be in place for both, radical surgery and adjuvant treatment.
Presence of tumour-related risk factors as follows:
Exclusion Criteria:
Radical hysterectomy, sentinel lymph node biopsy and systematic pelvic lymphadenectomy (PLND)\*. No further treatment will be administered. \*PLND can be avoided in patients with tumours \< 4cm
Radiation: No adjuvant therapy
Radical hysterectomy, sentinel lymph node biopsy and systematic pelvic lymphadenectomy (PLND)\*, followed by adjuvant treatment. \*PLND can be avoided in patients with tumours \< 4cm
Radiation: Adjuvant radiotherapy
Patients will not receive any type of adjuvant therapy.
Patients will receive adjuvant treatment composed of either pelvic radiotherapy external beam radiotherapy ± brachytherapy or concomitant chemoradiotherapy (pelvic radiotherapy + chemotherapy).
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.
Overall survival
Time frame: Analysed 6 years after randomization of the last patient.
Pelvic disease-free survival
Time frame: Analysed 3 years after randomization of the last patient.
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.
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.
Plan to share: No
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The Central and Eastern European Gynecologic Oncology Group