Induction Chemotherapy for Locally Recurrent Rectal Cancer

• Status: Recruiting
• Trial end date: 2030-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Criteria

Inclusion Criteria:

• 18 years or older

• Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal 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.

• Homozygous DPD deficiency

• Any chemotherapy in the past 6 months.

• Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction with creatinine clearance of <30ml/min, thrombocytopenia of <100x109/L), as determined by the medical oncologist.

• Radiotherapy in the past 6 months for primary rectal cancer.

• Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), 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.