NCT04989647RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 7 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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%).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 514 (estimated)
- First submitted
- 29 Jul 2021
- Start date
- 10 Jun 2022
- Primary completion date
- Dec 2029
- Lead sponsor
- The Central and Eastern European Gynecologic Oncology Group
- Diseases
- Cervical cancer
- NCT number
- NCT04989647
- EU CT number
- 2023-504973-19-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 514
- From 10 Jun 2022 to the primary completion date, Dec 2029
- 38 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic malignancy
- Previous pelvic radiotherapy
- Neoadjuvant chemotherapy prior surgical treatment
Other illness
- 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
Age
- History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)
Other
- Unequivocally positive lymph node by imaging (by radiological subjective assessment)
- FIGO \<IB1 / \>IIA
- Low likelihood of patient compliance to the follow-up
Who the study is looking for
- 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)
Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Feldkirch | Austria | Recruiting |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Steiermaerkische Krankenanstalten Ges.m.b.H. Coordinator of this site? Confirm its status | Leoben | Austria | Recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Katholieke Universiteit te Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Recruiting |
| Fakultni nemocnice Bulovka Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Recruiting |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario Infanta Sofia Coordinator of this site? Confirm its status | San Sebastián de los Reyes | Spain | Recruiting |
| Hospital Universitario Nuestra Señora de Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Medical University Of Silesia Katowice Poland Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Nemocnica BORY a.s. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Not yet recruiting |
| Vychodoslovensky Onkologicky Ustav a.s. Coordinator of this site? Confirm its status | Košice | Slovakia | Not yet recruiting |
| Fakultna nemocnica Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.