Feasibility of the Maastro Applicator in Rectal Cancer

Trial Title: Feasibility of the Maastro Applicator in Rectal Cancer

NCT ID: NCT06087718

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

Conditions: Official terms:
Rectal Neoplasms
Proctitis

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Maastro applicator
Description: 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.
Arm group label: Maastro applicator in combination with chemoradiotherapy

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: July 2024

Completion date: April 2031

Lead sponsor:
Agency: Maastricht Radiation Oncology
Agency class: Other

Collaborator:
Agency: Varian Medical Systems
Agency class: Industry

Source: Maastricht Radiation Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06087718