NCT06087718Active, not recruiting
Feasibility of the Maastro Applicator in Rectal Cancer
Introduction of the Maastro Applicator for Endoluminal Boosting in Rectal Cancer: a Pilot Study
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 27 Aug 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- Maastricht Radiation Oncology
- Diseases
- Colorectal cancer
- NCT number
- NCT06087718
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 27 Aug 2024 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiation therapy (excluding the abovementioned neoadjuvant treatment).
- Prior surgery or chemotherapy for rectal cancer (excluding the abovementioned neoadjuvant treatment).
Other illness
- Presence of coagulation disorder resulting in an increased bleeding risk.
- Inflammatory bowel disease (IBD).
- (Systemic) treatment possibly causing rectal or genitourinary toxicity for a separate active malignancy.
Other
- Tumor extending into the anal canal.
- Stop of anti-coagulants (except ≤100 mg aspirin/day) is medically contraindicated.
- World Health Organization performance status (WHO-PS) ≥ 3.
- Life expectancy of \< 6 months.
- Pregnant women.
Who the study is looking for
- ≥ 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastro Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.