Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
Recruiting · NCT05883800 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
On-couch adaptive radiotherapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Haukeland University Hospital - Bergen, Norway