Actively Recruiting
Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
Led by The Central and Eastern European Gynecologic Oncology Group · Updated on 2023-09-07
514
Participants Needed
1
Research Sites
546 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%).
CONDITIONS
Official Title
Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed invasive cervical cancer
- FIGO stage IB1 to IIA
- Squamous cell cancer or HPV-related adenocarcinoma
- Presence of tumor-related risk factors: tumor ≥4 cm, or tumor >2 cm and <4 cm with lymphovascular space invasion, or tumor >2 cm and <4 cm with tumor free distance <3 mm, or tumor >2 cm and <4 cm with deep stromal invasion (>2/3)
- No suspicious pelvic lymph nodes or distant metastases on imaging and negative pelvic lymph nodes on final pathology
- ECOG performance status of 0 or 1
- Suitable and fit for radical surgery followed by adjuvant radiotherapy
- Negative pregnancy test if applicable
- Negative HIV test if from or moved from high-risk countries within past 10 years
You will not qualify if you...
- Adenosquamous cancer or unusual type adenocarcinoma (non-HPV related) or other rare tumor types not listed in inclusion
- Inconclusive primary site of disease
- Clearly positive lymph node by imaging
- FIGO stage less than IB1 or greater than IIA
- Previous pelvic malignancy
- History of second primary cancer outside pelvis if less than or equal to 3 years complete clinical remission
- Previous pelvic radiotherapy
- Neoadjuvant chemotherapy before surgery
- Low likelihood of patient compliance with follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
General University Hospital in Prague
Prague, Czechia, 12000
Actively Recruiting
Research Team
M
Martina Borcinova, PhD
CONTACT
T
Trial Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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