REctal Organ Preservation With a BOost Approach Using CBCT-based Online Adaptive radioTherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
Study Overview
Brief Summary
The goal of this prospective study is to evaluate if a higher radiation dose to the tumor can increase the organ preservation rate in non-locally advanced rectal cancer.
Detailed Description
Rationale:
Organ preservation has emerged as a promising alternative to total mesorectal excision (TME) for non-locally advanced rectal cancer, aiming to reduce long-term functional impairments and improve quality of life. While magnetic resonance (MR)-guided radiotherapy boosts have shown potential in enhancing organ preservation rates, their high costs, prolonged treatment times and limited accessibility prevent widespread adoption. To address this gap in current treatment options, this study investigates a more accessible online adaptive boost strategy based on cone-beam computed tomography (CBCT) imaging, with the aim of expanding organ-preserving treatment options for rectal cancer patients.
Objective:
The primary objective of this study is to evaluate the organ preservation rate at two-year follow-up in patients with non-locally advanced rectal cancer. Secondary objectives include the assessment of clinical and pathological response rates, recurrence and survival outcomes, biological effects, treatment-related toxicities, bowel function, quality of life, tumor regression, CBCT-based workflow, and target and organ motion during treatment.
Study design:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Eastern cooperative oncology group (ECOG) performance status ≤2
- •Histologically confirmed rectal adenocarcinoma
- •Non-locally advanced rectal cancer, defined as (magnetic resonance imaging (MRI)-based) T1-3, N0/N1 (≤3 positive mesorectal lymph nodes), MX/M0
- •Indication for curative treatment with organ preservation
- •Discussed in the multidisciplinary tumor board (MTB)
- •Written informed consent
Exclusion Criteria
- •Previous radiotherapy in the pelvic area
- •Other malignancies, except for adequately treated basal cell carcinoma (BCC), at time of inclusion or within 3 years prior to inclusion
- •Contra-indications for (chemo)radiotherapy or surgery
- •Presence of lateral lymph nodes, cN2 status, extramural vascular invasion (EMVI) or mesorectal fascia involvement as seen on MRI
- •Mucinous defined tumor on MRI
- •Prior local excision of the primary tumor
- •DPD (dihydropyrimidine dehydrogenase) deficiency
- •Unable to understand the requirements of the study and to give written informed consent, as determined by the treating physician
Investigators
Claudia Schuurhuizen
Principal Investigator
Erasmus Medical Center