Status:
ACTIVE_NOT_RECRUITING
Feasibility of the Maastro Applicator in Rectal Cancer
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Rectal Cancer
Feasibility
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
The goal of this clinical trial is to confirm that Maastro endoluminal HDR contact brachytherapy boosting is feasible and may increase the chance of functional organ sparing of the rectum in patients ...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
August 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06087718
Start Date
August 27 2024
End Date
April 1 2031
Last Update
August 14 2025
Active Locations (1)
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1
Maastro
Maastricht, Limburg, Netherlands, 6229ET