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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 61 participants in total. It began in 2023-06-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Unn Hege Lilleøren, MD
PRINCIPAL INVESTIGATOR
Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway
Frequently Asked Questions
Who can join the NCT05883800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05883800 currently recruiting?
Yes, NCT05883800 is actively recruiting participants. Contact the research team at sara.margareta.cecilia.pilskog@helse-bergen.no for enrollment information.
Where is the NCT05883800 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT05883800 clinical trial?
NCT05883800 is sponsored by Haukeland University Hospital. The principal investigator is Unn Hege Lilleøren, MD at Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway. The trial plans to enroll 61 participants.
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