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 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%).
• 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)