Induction Chemotherapy for Recurrent Rectal Cancer
Induction Chemotherapy for Locally Recurrent Rectal Cancer
Recruiting
Phase 3Interventional Study
Recurrent Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
364 (estimated)
Sponsor
Catharina Ziekenhuis Eindhoven · Other
Who this trial is looking for
This trial is looking for adults with locally recurrent rectal cancer. Participants will receive either additional chemotherapy before standard treatment or the standard treatment alone.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have locally recurrent rectal cancer
My cancer can be removed by surgery
I have a good performance status
I can provide written consent
You may not be able to join if
I have metastatic disease to other organs
I have had any chemotherapy in the last 6 months
I received radiotherapy for rectal cancer in the last 6 months
I have any known contraindications for chemotherapy or surgery
I have any other cancers that affect my treatment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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)
Trial Locations
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Eligibility Criteria
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)
* Re…
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.
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