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RecruitingNot ApplicableNCT05883800

Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

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

Sponsor

Haukeland University Hospital

Enrollment

61 participants

Start Date

Jun 22, 2023

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

Interventions

RADIATIONOn-couch adaptive radiotherapy

A new treatment plan, guided by volumetric images, is created at each treatment session

Locations(1)

Haukeland University Hospital

Bergen, Norway

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NCT05883800

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