Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

Recruiting now · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT05883800

Run by

Haukeland University Hospital

People needed

61

Starts

2023-06-22

Expected to finish

2031-12-31

Last updated by the study team

2024-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Haukeland University Hospital — Bergen, Norway (enrolling)

Full record on ClinicalTrials.gov

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