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 range18 Years
SexALL
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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.
What they're measuring
1
Clinical feasibility of the Maastro boosting technique.