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Adaptive Radiotherapy Tested Before Surgery for Rectal Cancer

Tests adjusted radiation treatment before surgery in adults with rectal cancer.

Plain-language title generated from the registry record
Registry title: Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

Key facts

Where
Bergen, NorwaySee the site

Where in Norway

  • Haukeland University HospitalBergen, NorwayTaking people

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Trial details

Who runs it
Haukeland University Hospital
Trial code
NCT05883800
Record updated
19 March 2024
Original description
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).Read full original descriptionShow less

TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT05883800