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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
View on ClinicalTrials.gov →
NCT05883800
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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Actively Recruiting
PhaseN/A
SponsorHaukeland University Hospital
Started2023-06-22
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05883800