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Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

RecruitingNAAges 18 Years - anyAllHaukeland University Hospital
NCT05883800 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered. * ECOG status ≤ 1 * Being willing and able to give full written consent for participation Exclusion Criteria: * Previous rectal cancer treatment * Previous irradiation to the treatment area e.g. prostate cancer * Hip prosthesis * Contraindications to MRI * Pregnancy * Abnormal DPYD genotype * Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators
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What it tests

  • On-couch adaptive radiotherapy
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Where

1 site
Haukeland University Hospital
Bergen, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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