Feasibility of the Maastro Applicator in Rectal Cancer

NCT06087718 | Active Not Recruiting

• 1 other identifier: Feasibility Maastro applicator
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 sparing of the rectum in patients with rectal cancer. Participants will be treated with chemoradiotherapy and an endoluminal boost with the Maastro applicator.

Conditions

Rectal Cancer; Feasibility; Toxicity; Quality of Life; Radiation Toxicity; Radiation Proctitis; Brachytherapy; Complete Response

Outcome Measures

Primary Outcomes (1)

• Clinical feasibility of the Maastro boosting technique.

  If at least 7 out of 10 planned Maastro applicator treatment series (3 fractions per series) can be conducted successfully from a procedural point of view the treatment will be considered feasible.

  During treatment

Secondary Outcomes (18)

• Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum

  3 years follow-up

• Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.

  During treatment

• Duration of the application procedure.

  During treatment

• Percentage of patients with G3 or higher rectal toxicity up to 3 months after treatment potentially attributable to endoluminal HDR contact brachytherapy.

  3 months follow-up

• Clinical complete response rate up to 3 years after treatment.

  3 years follow-up

Other Outcomes (1)

• Collecting 3D ultrasound measurements of the gross tumor volume (GTV) and intestinal wall layers at every fraction of Maastro applicator brachytherapy.

  During treatment

Study Arms (1)

Maastro applicator in combination with chemoradiotherapy

EXPERIMENTAL

The intervention is similar to the treatment of arm B of the published OPERA trial, however the endoluminal boost will be given using the Maastro applicator instead of a CXRT device.

Device: Maastro applicator

Interventions

Maastro applicator DEVICE

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.

Maastro applicator in combination with chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Maastro

Maastricht, Limburg, 6229ET, Netherlands

Location

Related Publications (3)

• Bellezzo M, Fonseca GP, Verrijssen AS, Voncken R, Van den Bosch MR, Yoriyaz H, Reniers B, Berbee M, Van Limbergen EJ, Verhaegen F. A novel rectal applicator for contact radiotherapy with HDR 192Ir sources. Brachytherapy. 2018 Nov-Dec;17(6):1037-1044. doi: 10.1016/j.brachy.2018.07.012. Epub 2018 Aug 16.

  PMID: 30122346 BACKGROUND

• Bellezzo M, Fonseca GP, Voncken R, Verrijssen AS, Van Beveren C, Roelofs E, Yoriyaz H, Reniers B, Van Limbergen EJ, Berbee M, Verhaegen F. Advanced design, simulation, and dosimetry of a novel rectal applicator for contact brachytherapy with a conventional HDR 192Ir source. Brachytherapy. 2020 Jul-Aug;19(4):544-553. doi: 10.1016/j.brachy.2020.03.009. Epub 2020 May 6.

  PMID: 32386884 BACKGROUND

• Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.

  PMID: 36801007 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Radiation Injuries; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Wounds and Injuries; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maaike Berbée, MD, PhD

  Maastro, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single arm prospective interventional pilot trial in 10 patients with feasibility and safety checks and early stopping/intermission rules

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 18, 2023
• Study Start: August 27, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2031
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)