Clinical trial · Interventional
Feasibility of the Maastro Applicator in Rectal Cancer
Introduction of the Maastro Applicator for Endoluminal Boosting in Rectal Cancer: a Pilot Study
NCT06087718CI-TRIAL-00093607active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brachytherapy | — | UNRESOLVED | — |
| Complete Response | — | UNRESOLVED | — |
| Feasibility | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Radiation Proctitis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maastro applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maastro applicator in combination with chemoradiotherapy
- description
- 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.
- interventionNames
- Device: Maastro applicator
Primary outcomes (1)
- measure
- Clinical feasibility of the Maastro boosting technique.
- timeFrame
- During treatment
- description
- 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.
Secondary outcomes (18)
- measure
- Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDBellezzo 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
- BACKGROUNDBellezzo 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
- BACKGROUNDGerard 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