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ACTIVE NOT RECRUITING
NCT06087718
NA

Feasibility of the Maastro Applicator in Rectal Cancer

Sponsor: Maastricht Radiation Oncology

View on ClinicalTrials.gov

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.

Official title: Introduction of the Maastro Applicator for Endoluminal Boosting in Rectal Cancer: a Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-08-27

Completion Date

2031-04

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

DEVICE

Maastro applicator

The dose profile of the Maastro applicator is similar to the dose profile of a CXRT device. Patients will be stratified based on tumor size. The cut-off is set at the maximum diameter of the treatment surface of the Maastro applicator. The boost consists of 3 fractions with a dose equivalent to 30 Gy per fraction prescribed at the surface of the applicator. The 3 boost fractions will be delivered over a 4-week time period. Patients with a tumor size \< 2.5 cm will receive an upfront boost followed by concurrent chemoradiotherapy (25x1.8 Gy combined with capecitabine 825 mg/m2 bd on radiotherapy days). Patients with a tumor size ≥ 2.5cm will first undergo concurrent chemoradiotherapy (25x1.8 Gy combined with capecitabine 825 mg/m2 bd on radiotherapy days) and will afterwards receive the boost.

Locations (1)

Maastro

Maastricht, Limburg, Netherlands