Feasibility of the Maastro Applicator in Rectal Cancer (NCT06087718) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Feasibility of the Maastro Applicator in Rectal Cancer
Netherlands10 participantsStarted 2024-08-27
Plain-language summary
The goal of this interventional pilot trial is to confirm that Maastro endoluminal HDR ( High Dose Radiation) contact brachytherapy boosting is feasible and may increase the chance of functional organ sparing of the rectum in patients with rectal cancer. Participants will be treated with chemoradiotherapy and an endoluminal boost with the Maastro applicator.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years of age and capable of giving informed consent.
* Adenocarcinoma of the rectum classified cT (clinical Tumor) 2-3b, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (any node \< 8 mm diameter), M0
* Operable patient
* Tumor accessible to the Maastro applicator with a distance from the lower tumor border to the anal verge ≤10 cm
* No comorbidity preventing treatment
* Adequate birth control for women of child-bearing potential
* Follow-up possible.
Exclusion Criteria:
* Tumor extending into the anal canal.
* Stop of anti-coagulants (except ≤100 mg aspirin/day) is medically contraindicated.
* Presence of coagulation disorder resulting in an increased bleeding risk.
* Prior pelvic radiation therapy (excluding the abovementioned neoadjuvant treatment).
* Prior surgery or chemotherapy for rectal cancer (excluding the abovementioned neoadjuvant treatment).
* Inflammatory bowel disease (IBD).
* (Systemic) treatment possibly causing rectal or genitourinary toxicity for a separate active malignancy.
* World Health Organization performance status (WHO-PS) ≥ 3.
* Life expectancy of \< 6 months.
* Pregnant women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical feasibility of the Maastro boosting technique.