Induction Chemotherapy for Locally Recurrent Rectal Cancer

Launched by CATHARINA ZIEKENHUIS EINDHOVEN · May 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally recurrent rectal cancer, which means the cancer has come back after it was previously treated. The trial is comparing two groups: one group will receive a combination of initial chemotherapy followed by chemoradiotherapy (which is a mix of chemotherapy and radiation) and surgery, while the other group will receive only chemoradiotherapy and surgery. The goal is to see if adding chemotherapy before the standard treatment can help improve outcomes for patients.

To be eligible for this trial, participants must be at least 18 years old and have confirmed locally recurrent rectal cancer that can still be surgically removed. They should also be in good overall health, as assessed by a performance score. The trial is currently recruiting patients of all genders, aged between 65 and 74. Participants will need to give written consent to join the study. If you or someone you know is considering this trial, it’s important to discuss any past treatments or health conditions with the medical team, as there are certain criteria that could exclude someone from participating. Throughout the trial, patients can expect close monitoring and support from healthcare professionals.

Gender

ALL

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)
• • 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.