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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
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

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
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FeldkirchAustriaRecruiting
Medical University of Graz
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GrazAustriaRecruiting
Steiermaerkische Krankenanstalten Ges.m.b.H.
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LeobenAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Katholieke Universiteit te Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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NamurBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Fakultni Nemocnice Plzen
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Plzen 23CzechiaRecruiting
Fakultni nemocnice Bulovka
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PragueCzechiaRecruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaRecruiting
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Donostia
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DonostiaSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Hospital Universitario Infanta Sofia
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San Sebastián de los ReyesSpainRecruiting
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
Medical University Of Silesia Katowice Poland
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KatowicePolandRecruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandRecruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
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SiedlcePolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandRecruiting
Nemocnica BORY a.s.
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BratislavaSlovakiaNot yet recruiting
Vychodoslovensky Onkologicky Ustav a.s.
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KošiceSlovakiaNot yet recruiting
Fakultna nemocnica Trencin
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TrenčínSlovakiaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.