Feasibility of the Maastro Applicator in Rectal Cancer

Launched by MAASTRICHT RADIATION ONCOLOGY · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method for patients with rectal cancer using a device called the Maastro applicator. The goal is to see if this approach can safely deliver high doses of radiation directly to the tumor while sparing healthy tissue in the rectum. Participants will receive a combination of chemotherapy and radiation, including this new treatment, to see if it helps improve their chances of recovery while minimizing side effects.

To join the trial, participants need to be at least 18 years old and have a specific type of rectal cancer that can be treated with this method. They should not have had previous pelvic radiation or surgeries for rectal cancer, and their tumors must be in a location that the Maastro applicator can reach. If someone is selected for the trial, they will be closely monitored during treatment to ensure their safety and to check how well the treatment works. This study is currently not recruiting participants but aims to gather important information to improve treatment for rectal cancer in the future.

Gender

ALL

Eligibility criteria

• 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.