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โ† Trials
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Induction Chemotherapy for Locally Recurrent Rectal Cancer

RecruitingPhase 3Ages 18 Years - anyAllCatharina Ziekenhuis Eindhoven
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In plain words

What the trial is, and whether it could suit you

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)

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology รณr 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 Exclusion Criteria: * Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. * Known homozygous DPD deficiency * Any chemotherapy in the past 6 months. * Any contraindication for the planned chemotherapy, as determined by the medical oncologist. * Radiotherapy in the past 6 months for primary rectal cancer. * 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.
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What it tests

  • Combination drug
  • Chemoradiotherapy
  • Surgery locally recurrent rectal cancer
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Where

14 sites
UZ Gent
Ghent, Belgium
Amsterdam UMC
Amsterdam, Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Catharina Hospital
Eindhoven, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
Leids University Medical Centre
Leiden, Netherlands
Haaglanden Medical Centre
Leidschendam, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands

โ€ฆand 6 more on ClinicalTrials.gov.

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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