Induction Chemotherapy for Locally Recurrent Rectal Cancer (PelvEx II)

  • End date
    Mar 1, 2030
  • participants needed
  • sponsor
    Catharina Ziekenhuis Eindhoven
Updated on 7 October 2022


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)

Condition Recurrent Rectal Cancer
Treatment Chemoradiotherapy, Combination drug, Surgery locally recurrent rectal cancer
Clinical Study IdentifierNCT04389086
SponsorCatharina Ziekenhuis Eindhoven
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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

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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