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โ† Trials
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Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy

RecruitingPhase 3Ages 18 Years - 85 YearsFemaleThe Central and Eastern European Gynecologic Oncoโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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%).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ4 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 โ‰ค 3 years complete clinical remission (CCR) * Previous pelvic radiotherapy * Neoadjuvant chemotherapy prior surgical treatment * Low likelihood of patient compliance to the follow-up
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What it tests

  • No adjuvant therapy
  • Adjuvant radiotherapy
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Where

1 site
General University Hospital in Prague
Prague, Czechia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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