Feasibility of the Maastro Applicator in Rectal Cancer

NAActive, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 27, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2031

Conditions
Rectal CancerFeasibilityToxicityQuality of LifeRadiation ToxicityRadiation ProctitisBrachytherapyComplete Response
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.

Trial Locations (1)

6229ET

Maastro, Maastricht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Varian Medical Systems

INDUSTRY

lead

Maastricht Radiation Oncology

OTHER