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NCT04389086RecruitingPhase 3

Induction Chemotherapy for Locally Recurrent Rectal Cancer

Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II

Source: ClinicalTrials.gov · Last updated 6 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
364 (estimated)
First submitted
7 May 2020
Start date
13 Nov 2020
Primary completion date
1 Mar 2024
Lead sponsor
Catharina Ziekenhuis Eindhoven
NCT number
NCT04389086
EU CT number
2024-512526-28-00
EudraCT number
2020-002141-42

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 364
  • From 13 Nov 2020 to the primary completion date, 1 Mar 2024
  • 33 sites in 5 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

  • Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
  • Any chemotherapy in the past 6 months.
  • Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
  • Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist.
  • Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
  • Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.

Other illness

  • Radiotherapy in the past 6 months for primary rectal cancer.

Other

  • Known homozygous DPD deficiency

Who the study is looking for

  • 18 years or older
  • Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
  • Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
  • WHO performance score 0-1
  • Written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

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

SiteCityCountrySite status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
Noordwest Ziekenhuisgroep Stichting
Coordinator of this site? Confirm its status
AlkmaarNetherlandsRecruiting
Academic Medical Center at the University of Amsterdam
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Gelre Hospitals
Coordinator of this site? Confirm its status
ApeldoornNetherlandsRecruiting
Rijnstate Ziekenhuis Stichting
Coordinator of this site? Confirm its status
ArnhemNetherlandsRecruiting
Radiotherapiegroep
Coordinator of this site? Confirm its status
ArnhemNetherlandsRecruiting
Amphia Hospital
Coordinator of this site? Confirm its status
BredaNetherlandsRecruiting
Catharina Ziekenhuis Stichting
Coordinator of this site? Confirm its status
EindhovenNetherlandsRecruiting
Medisch Spectrum Twente
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EnschedeNetherlandsRecruiting
Admiraal De Ruyter Ziekenhuis B.V.
Coordinator of this site? Confirm its status
GoesNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Medisch Centrum Leeuwarden B.V.
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LeeuwardenNetherlandsRecruiting
Radiotherapeutisch Instituut Friesland
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LeeuwardenNetherlandsRecruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsRecruiting
Medical Center Haaglanden
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LeidschendamNetherlandsRecruiting
Maastro Clinic
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MaastrichtNetherlandsRecruiting
University Hospital Maastricht
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MaastrichtNetherlandsRecruiting
Sint Antonius Ziekenhuis Stichting
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NieuwegeinNetherlandsRecruiting
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsRecruiting
Bravis Ziekenhuis
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RoosendaalNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Jeroen Bosch Ziekenhuis
Coordinator of this site? Confirm its status
's-HertogenboschNetherlandsRecruiting
Dr. Bernard Verbeeten Instituut Stichting
Coordinator of this site? Confirm its status
TilburgNetherlandsRecruiting
Elisabeth-Tweesteden Ziekenhuis
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TilburgNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Zuidwest Radiotherapeutisch Instituut
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VlissingenNetherlandsRecruiting
Isala Klinieken Stichting
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ZwolleNetherlandsRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Karolinska University Hospital
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StockholmSwedenRecruiting

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