Induction Chemotherapy for Locally Recurrent Rectal Cancer
ConditionRecurrent Rectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatharina Ziekenhuis Eindhoven
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Combination drug
- Chemoradiotherapy
- Surgery locally recurrent rectal cancer
Treatment groups
364 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov