Last updated: September 5, 2023
Sponsor: The Central and Eastern European Gynecologic Oncology Group
Overall Status: Active - Recruiting
Phase
3
Condition
Dysfunctional Uterine Bleeding
Cervical Cancer
Vaginal Cancer
Treatment
No adjuvant therapy
Adjuvant radiotherapy
Clinical Study ID
NCT04989647
ENGOT-cx16/CEEGOG/CERVANTES
Ages 18-85 Female
Study Summary
Eligibility Criteria
Inclusion
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:
- 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)
- No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (byradiological subjective assessment before surgery and negative pelvic LN on finalpathology)
- 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 movedfrom those countries within the past 10 years)
Exclusion
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 theinclusion 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 clinicalremission (CCR)
- Previous pelvic radiotherapy
- Neoadjuvant chemotherapy prior surgical treatment
- Low likelihood of patient compliance to the follow-up
Study Design
Total Participants: 514
Treatment Group(s): 2
Primary Treatment: No adjuvant therapy
Phase: 3
Study Start date:
June 10, 2022
Estimated Completion Date:
December 31, 2032
Study Description
Connect with a study center
General University Hospital in Prague
Prague, 12000
CzechiaActive - Recruiting
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