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Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

RECRUITINGN/ASponsored by Haukeland University Hospital
Actively Recruiting
PhaseN/A
SponsorHaukeland University Hospital
Started2023-06-22
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerRectal Cancer

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