Induction Chemotherapy for Locally Recurrent Rectal Cancer

Last updated: September 1, 2022
Sponsor: Catharina Ziekenhuis Eindhoven
Overall Status: Active - Recruiting

Phase

3

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT04389086
NL73593
  • Ages > 18
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older
  • Confirmed locally recurrent rectal cancer after total or partial mesorectal resectionfor 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 resectableafter neoadjuvant treatment with chemoradiotherapy.
  • WHO performance score 0-1
  • Written informed consent

Exclusion

Exclusion Criteria:

  • Radiological evidence of metastatic disease (e.g. liver, lung) at time ofrandomisation 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 medicaloncologist.
  • Radiotherapy in the past 6 months for primary rectal cancer.
  • Any contraindication for the planned chemoradiotherapy, as determined by the medicaloncologist and/or radiation oncologist.
  • Any contraindication for surgery, as determined by the surgeon and/oranaesthesiologist.
  • Concurrent malignancies that interfere with the planned study treatment or theprognosis of resected LRRC.

Study Design

Total Participants: 364
Study Start date:
November 13, 2020
Estimated Completion Date:
March 01, 2030

Connect with a study center

  • UZ Gent

    Gent,
    Belgium

    Site Not Available

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Catharina Hospital

    Eindhoven, 5623EJ
    Netherlands

    Active - Recruiting

  • University Medical Centre Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Leids University Medical Centre

    Leiden,
    Netherlands

    Active - Recruiting

  • Haaglanden Medical Centre

    Leidschendam,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Centre

    Maastricht,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Centre

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Oslo Universitetssykehus

    Oslo,
    Norway

    Site Not Available

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

    Lisbon,
    Portugal

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Göteborg,
    Sweden

    Site Not Available

  • Skåne Universitetssjukhuset

    Malmö,
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset

    Stockholm,
    Sweden

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.