The Central and Eastern European Gynecologic Oncology Group
Phase
Phase 3
Started
2022-06-10
Last updated
2023-09-07
Condition(s) studied
Cervical Cancer
Investigational drug(s) / intervention(s)
No adjuvant therapyAdjuvant radiotherapy
No adjuvant therapy: Patients will not receive any type of adjuvant therapy.
Adjuvant radiotherapy: Patients will receive adjuvant treatment composed of either pelvic radiotherapy external beam radiotherapy ± brachytherapy or concomitant chemoradiotherapy (pelvic radiotherapy + chemotherapy).
Study summary
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
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Pathologically confirmed invasive cervical cancer
* FIGO IB1-IIA
* Squamous cell cancer or HPV-related adenocarcinoma
* Presence of tumour-related risk factors as follows:
1. tumour ≥4 cm OR
2. tumour\>2 cm \<4 cm AND lymphovascular space invasion OR
3. tumour \>2 cm \<4 cm AND tumour free distance \<3 mm OR
4. tumour \>2 cm \<4 cm AND deep stromal invasion (\>2/3)
* No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (by radiological subjective assessment before surgery and negative pelvic LN on final pathology)
* ECOG performance status 0-1
* Deemed suitable and fit for radical surgery followed by adjuvant radiotherapy
* Negative pregnancy test (if applicable)
* Negative HIV test (only performed in high-risk countries or patients who have moved from those countries within the past 10 years)
Exclusion Criteria:
* 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
* Previous pelvic malignancy
* History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)
* Previous pelvic radiotherapy
* Neoadjuvant chemotherapy prior surgical treatment
* Low likelihood of patient compliance to the follow-up
Primary outcome measure(s)
Disease-free survival — Analysed 3 years after randomization of the last patient. 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.
Trial sites (1)
Facility
City
Region
Status
General University Hospital in Prague
Prague
Czechia
Recruiting
More The Central and Eastern European Gynecologic Oncology Group trials in Czechia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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