NCT04989647 Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
| NCT ID | NCT04989647 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Central and Eastern European Gynecologic Oncology Group |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 514 participants |
| Start Date | 2022-06-10 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 514 participants in total. It began in 2022-06-10 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
David Cibula, prof.
PRINCIPAL INVESTIGATOR
General University Hospital in Prague, Czech Republic
Frequently Asked Questions
Who can join the NCT04989647 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04989647 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 514 participants.
Is NCT04989647 currently recruiting?
Yes, NCT04989647 is actively recruiting participants. Contact the research team at martina.borcinova@cervantes-trial.com for enrollment information.
Where is the NCT04989647 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT04989647 clinical trial?
NCT04989647 is sponsored by The Central and Eastern European Gynecologic Oncology Group. The principal investigator is David Cibula, prof. at General University Hospital in Prague, Czech Republic. The trial plans to enroll 514 participants.
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