Combining adaptive radiotherapy with total neoadjuvant treatment for rectal cancer
TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
This study is testing if personalized radiation treatment can help people with advanced rectal cancer have fewer side effects and finish their chemotherapy more easily before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bergen) |
| Trial ID | NCT05883800 on ClinicalTrials.gov |
What this trial studies
This study investigates the benefits of on-couch adaptive radiotherapy for patients with locally advanced rectal cancer undergoing pre-operative sequential short-course radiotherapy followed by chemotherapy. The approach tailors the radiation dose to the patient's anatomy during each session, aiming to reduce gastrointestinal adverse events. Additionally, the study will assess whether this reduction allows more patients to complete their prescribed chemotherapy cycles. It is a prospective single-arm study focusing on improving treatment outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with locally advanced rectal adenocarcinoma who meet specific clinical criteria for short-course treatment and are willing to participate.
Not a fit: Patients with previous rectal cancer treatment or those with contraindications to the chemotherapy agents used in the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could lead to fewer side effects and improved completion rates of chemotherapy for rectal cancer patients.
How similar studies have performed: While the specific combination of adaptive radiotherapy and total neoadjuvant treatment is novel, similar approaches have shown promise in reducing adverse effects in other cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Principal investigator: Unn Hege Lilleøren, MD — Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway
- Study coordinator: Sara Pilskog, PhD
- Email: sara.margareta.cecilia.pilskog@helse-bergen.no
- Phone: 95890659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.