NCT05883800Recruiting
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
Source: ClinicalTrials.gov · Last updated 19 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- First submitted
- 24 Feb 2023
- Start date
- 22 Jun 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05883800
What you commit to
- Study type: Interventional
- Planned participants: 61
- From 22 Jun 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous rectal cancer treatment
- Previous irradiation to the treatment area e.g. prostate cancer
Other
- Hip prosthesis
- Contraindications to MRI
- Pregnancy
- Abnormal DPYD genotype
- Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.