Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
An International Randomised Trial of Radical Surgery Followed by Adjuvant (Chemo)Radiation Versus no Further Treatment in Patients With Early-stage, Intermediate-risk Cervical Cancer Patients
The Central and Eastern European Gynecologic Oncology Group
514 participants
Jun 10, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria21
- 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 (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)
- 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
Interventions
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).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04989647