Surgery Followed by Radiotherapy or Observation for Early-Stage Cervical Cancer
Tests whether radiation after surgery helps adults with early intermediate-risk cervical cancer.
Plain-language title generated from the registry record
Registry title: Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
Key facts
- Where
- Rome, ItalySee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT04989647, who can take part
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Central and Eastern European Gynecologic Oncology Group
- Trial code
- NCT04989647EU 2023-504973-19-01
- Record updated
- 7 September 2023
- Original description
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%).Read full original descriptionShow less
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%).
Inclusion: 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).
Exclusion: Previous pelvic malignancy; Previous pelvic radiotherapy; Neoadjuvant chemotherapy prior surgical treatment; 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; History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR); Unequivocally positive lymph node by imaging (by radiological subjective assessment); FIGO <IB1 / >IIA; Low likelihood of patient compliance to the follow-up.