Induction chemotherapy for recurrent rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, phase III study aims to evaluate the effectiveness of induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery in patients with locally recurrent rectal cancer. Participants will be randomly assigned in a 1:1 ratio to either the experimental arm receiving induction chemotherapy or the control arm receiving standard neoadjuvant chemoradiotherapy and surgery. The study seeks to determine if the addition of induction chemotherapy improves surgical outcomes and resection margins. The trial will involve multiple locations and will assess patient responses through imaging and clinical evaluations.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting
• Catharina Hospital
  Eindhoven, Netherlands Recruiting
• University Medical Centre Groningen
  Groningen, Netherlands Recruiting
• Leids University Medical Centre
  Leiden, Netherlands Recruiting
• Haaglanden Medical Centre
  Leidschendam, Netherlands Recruiting

Study contacts

• Principal investigator: Pim Burger, MD — Catharina Ziekenhuis Eindhoven
• Study coordinator: Stefi Nordkamp, MD
• Email: stefi.nordkamp@catharinaziekenhuis.nl
• Phone: 0031 40 2398858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.