NCT05883800 Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
| NCT ID | NCT05883800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 61 participants |
| Start Date | 2023-06-22 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
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
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.