Feasibility of the Maastro Applicator in Rectal Cancer

NCT ID: NCT06087718

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-27
• Study Completion Date: 2031-04-30

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.

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 with rectal cancer. 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. The study intervention will be similar to the study treatment of arm B of the OPERA trial. Opposed to the treatment in arm B of the OPERA trial, the endoluminal boost will be given using HDR brachytherapy with the Maastro applicator instead of a CXRT (Contact X-ray Radiotherapy) device. The dose profile of the Maastro applicator is similar to the dose profile of CXRT device. As in the OPERA trial patients will be stratified based on tumor size. As the diameter of the treatment field of the largest Maastro applicator (there are two sizes) equals 2.5 cm we will stratify for tumor diameter < 2.5 cm v ≥ 2.5 cm. In the OPERA trial patients were stratified for a tumor diameter of < 3.0 cm v ≥ 3.0 cm as currently the largest applicator diameter for the CXRT device is 3.0 cm (currently available applicators: 2.0, 2.5 and 3.0 cm). The endoluminal boost will consist 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 (week 1-2-4). Conform OPERA protocol, patients with a tumor size < 2.5 cm will receive an upfront endoluminal HDR contact boost followed by concurrent chemoradiotherapy (25x1.8 Gy combined with capecitabine 825 mg/m2 bd on radiotherapy days). Patients with a tumor size ≥ 2.5 cm will first undergo concurrent chemoradiotherapy (25x1.8 Gy combined with capecitabine 825 mg/m2 bd on radiotherapy days) to first shrink the tumor and will receive the endoluminal HDR contact boost afterwards in order to eventually fit the tumor surface in the surface of the Maastro applicator.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maastro applicator in combination with chemoradiotherapy

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.

Group Type: EXPERIMENTAL

Maastro applicator

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maaike Berbée, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastro, the Netherlands

Locations

Maastro

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 30122346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32386884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36801007 (View on PubMed)

Other Identifiers

Feasibility Maastro applicator

Identifier Type: -

Identifier Source: org_study_id