Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy

Recruiting now · Phase 3

Conditions studied: Cervical Cancer

In brief

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%).

Key facts

Study ID

NCT04989647

Run by

The Central and Eastern European Gynecologic Oncology Group

People needed

514

Starts

2022-06-10

Expected to finish

2032-12-01

Last updated by the study team

2023-09-07

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• General University Hospital in Prague — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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