Combining adaptive radiotherapy with total neoadjuvant treatment for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.