Rectal CancerNCT06087718
Feasibility of the Maastro Applicator in Rectal Cancer
A study testing Maastro applicator in people with Rectal Cancer and Feasibility, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Feasibility, Toxicity
- What is being tested?
- Maastro applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Aug 2024to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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).
Show all 10Show fewer
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction of the Maastro Applicator for Endoluminal Boosting in Rectal Cancer: a Pilot Study
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.
Read the 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
- Being tested
- Maastro applicator
- Medical subject headings
- Rectal Neoplasms, Radiation Injuries, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maastro applicatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Maastro applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During treatment
Secondary outcomes (18)
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum
Percentage of patients with a persistent clinical complete response with good rectal function (no irreversible G2 or higher toxicity that does not respond to treatment) at 3 years.
(number of patients with a complete response AND no persistent G2 or higher rectal toxicity) / (total number of patients) * 100%
Measured: 3 years follow-up
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
(procedures conducted successfully from a procedural point of view according to the checklist, please refer to appendix A) / (total number of procedures) * 100%
Measured: During treatment
Duration of the application procedure.
Time from insertion of the proctoscope to finalising removal of the proctoscope in minutes.
Measured: During treatment
Percentage of patients with G3 or higher rectal toxicity up to 3 months after treatment potentially attributable to endoluminal HDR contact brachytherapy.
Doctor reported CTCEA (Common Terminology Criteria for Adverse Events) v. 5 G3 or higher rectal toxicity not present before the start of treatment and occurring up to 3 months after treatment potentially attributable to endoluminal radiotherapy.
(number of patients with new G3 or higher rectal toxicity up to 3 months after treatment) / (total number of patients) * 100%
Measured: 3 months follow-up
Clinical complete response rate up to 3 years after treatment.
Clinical response will be assessed using the "watch and wait" protocol which is part of standard clinical care at MUMC+ ( Maastricht Medical University Center). Data will be reported at 3 months, 6 months, 1 year, 2 years and 3 years of follow-up.
(number of patients with a cCR) / (total number of patients) * 100%
Measured: 3 years follow-up
Rectal toxicity scored according to CTCAE v. 5 up to 3 years after treatment.
Both patient and doctor reported rectal toxicity scored according to CTCEA v. 5 will be determined before each application procedure, weekly during chemoradiotherapy, 1 week after treatment and 1, 3, 6, 12, 18, 24 and 36 months after treatment.
Measured: 3 years follow-up
Genitourinary toxicity scored according CTCAE v. 5 up to 3 years after treatment.
Both patient and doctor reported genitourinary toxicity scored according to CTCEA v. 5 will be determined before each application procedure, weekly during chemoradiotherapy, 1 week after treatment and 1, 3, 6, 12, 18, 24 and 36 months after treatment.
Measured: 3 years follow-up
Health status and quality of life as measured by QLQ (quality of life questionnaire)-C30 up to 3 years after treatment.
Patients will fill out the validated health status and quality of life questionnaire QLQ-C30 after inclusion (at baseline) and 1, 3, 6, 12, 18, 24 and 36 months after treatment.
Measured: 3 years follow-up
Health status and quality of life as measured by QLQ-CR29 (Colo Rectal) up to 3 years after treatment.
Patients will fill out the validated health status and quality of life questionnaire QLQ-CR29 after inclusion (at baseline) and 1, 3, 6, 12, 18, 24 and 36 months after treatment.
Measured: 3 years follow-up
Health status and quality of life as measured by EQ-5D (EuroQol Five Dimensions Health Questionnaire) up to 3 years after treatment.
Patients will fill out the EQ-5D-5L after inclusion (at baseline) and 1, 3, 6, 12, 18, 24 and 36 months after treatment.
Measured: 3 years follow-up
Long-term rectal functional outcome as measured by LARS 9 Low Anterior Resection Syndrome) score up to 3 years after treatment.
Patients will fill out the LARS questionnaire after inclusion (at baseline) and 1, 3, 6, 12, 18, 24 and 36 months after treatment.
Measured: 3 years follow-up
Local recurrence rate up to 5 years after treatment.
Local recurrence rate is defined as the rate of rectal recurrences at the site of the initial primary tumor. Local recurrence rate will be registered up to 5 years after treatment by consulting the hospital patient file.
(number of patients with a local recurrence) / (total number of patients) * 100%
Measured: 5 years follow-up
Locoregional recurrence rate up to 5 years after treatment.
Locoregional recurrence rate is defined as the rate of recurrences in the rectum and the regional pelvic lymph node areas. Locoregional recurrence rate will be registered up to 5 years after treatment by consulting the hospital patient file.
(number of patients with a locoregional recurrence) / (total number of patients) * 100%
Measured: 5 years follow-up
Metastatic rate up to 5 years after treatment.
Metastatic rate is defined as the rate of distant metastasis. Metastatic rate will be registered up to 5 years after treatment by consulting the hospital patient file.
(number of patients with distant metastases) / (total number of patients) * 100%
Measured: 5 years follow-up
Salvage surgery rate after treatment.
The percentage of patients undergoing salvage surgery will be determined. Both TME and local excision rate will be reported separately and combined. The reason for surgery (e.g. local recurrence, patient's wish, unacceptable toxicity) if available and the pathologic outcome (e.g. pCR) will also be reported for patients undergoing surgery. Salvage surgery rate will be registered up to 5 years after treatment by consulting the hospital patient file.
(number of patients undergoing salvage surgery) / (total number of patients) * 100%
Measured: 5 years follow-up
Overall and disease specific survival rate up to 5 year after treatment.
Both overall survival rate and disease specific survival rates will be reported. Survival rate will be registered up to 5 years after treatment by consulting the hospital patient file.
100% - (number of patients having died within 5 years after treatment [due to any causes or due to rectal cancer] / total number of patients * 100%)
Measured: 5 years follow-up
The diagnostic value of clinical response assessment using digital rectal examination, endoscopy and MRI after endoluminal radiation boosting using the Maastro applicator.
Clinical response will be assessed using the "watch and wait" protocol which is part of standard clinical care at MUMC+. According to this protocol tumor response is assessed using a digital rectal examination, sigmoidoscopy and MRI (including T2 and DWI). This combined modality approach has been reported to have a specificity of 97% and a sensitivity of 71% for the detection of complete tumor response after neoadjuvant (chemo)radiotherapy. The exact diagnostic value of this multimodality approach has not been validated in the setting of an endoluminal boost with the Maastro applicator. We will evaluate the diagnostic value by relating the test results to a persistent clinical complete response at 1 and 2 years, residual tumor (yes/no) in the resection specimen in case of salvage surgery and a clinical local recurrence in case of refusal of salvage surgery.
Measured: during follow-up
Complications within the first 30 days after completion of salvage total mesorectal excision (TME) surgery up to 3 years after treatment.
Complications within the first 30 days after completion or salvage TME surgery will be scored according to the classification of surgical complications by Clavien-Dindo (16). Complications will be registered up to 3 years after treatment by consulting the hospital patient file.
Measured: 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start27 Aug 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm prospective interventional pilot trial in 10 patients with feasibility and safety checks and early stopping/intermission rules
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Maaike Berbée, MD, PhD, Principal investigator, Maastro, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087718
- Sponsor's protocol ID
- Feasibility Maastro applicator
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30122346Bellezzo 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.
PubMed 32386884Gerard 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.
PubMed 36801007
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of the Maastro Applicator for Endoluminal Boosting in Rectal Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT06087718
- Acronym / sponsor ID
- Feasibility Maastro applicator
- Conditions
- Rectal Cancer, Feasibility, Toxicity, Quality of Life, Radiation Toxicity, Radiation Proctitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm prospective interventional pilot trial in 10 patients with feasibility and safety checks and early stopping/intermission rules
| Arm | Type | Receives |
|---|---|---|
| Maastro applicator in combination with chemoradiotherapy | Experimental | Device: Maastro applicatorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maastro applicatorThe 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. | Device | Maastro applicator in combination with chemoradiotherapy |
Primary outcome
Clinical feasibility of the Maastro boosting technique.
Time frame: During treatment
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.
18 secondary outcomes
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum
Time frame: 3 years follow-up
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Time frame: During treatment
Duration of the application procedure.
Time frame: During treatment
Percentage of patients with G3 or higher rectal toxicity up to 3 months after treatment potentially attributable to endoluminal HDR contact brachytherapy.
Time frame: 3 months follow-up
Clinical complete response rate up to 3 years after treatment.
Time frame: 3 years follow-up
Rectal toxicity scored according to CTCAE v. 5 up to 3 years after treatment.
Time frame: 3 years follow-up
Genitourinary toxicity scored according CTCAE v. 5 up to 3 years after treatment.
Time frame: 3 years follow-up
Health status and quality of life as measured by QLQ (quality of life questionnaire)-C30 up to 3 years after treatment.
Time frame: 3 years follow-up
Health status and quality of life as measured by QLQ-CR29 (Colo Rectal) up to 3 years after treatment.
Time frame: 3 years follow-up
Health status and quality of life as measured by EQ-5D (EuroQol Five Dimensions Health Questionnaire) up to 3 years after treatment.
Time frame: 3 years follow-up
Long-term rectal functional outcome as measured by LARS 9 Low Anterior Resection Syndrome) score up to 3 years after treatment.
Time frame: 3 years follow-up
Local recurrence rate up to 5 years after treatment.
Time frame: 5 years follow-up
Locoregional recurrence rate up to 5 years after treatment.
Time frame: 5 years follow-up
Metastatic rate up to 5 years after treatment.
Time frame: 5 years follow-up
Salvage surgery rate after treatment.
Time frame: 5 years follow-up
Overall and disease specific survival rate up to 5 year after treatment.
Time frame: 5 years follow-up
The diagnostic value of clinical response assessment using digital rectal examination, endoscopy and MRI after endoluminal radiation boosting using the Maastro applicator.
Time frame: during follow-up
Complications within the first 30 days after completion of salvage total mesorectal excision (TME) surgery up to 3 years after treatment.
Time frame: 3 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 30122346Bellezzo 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.
- Background: PubMed 32386884Bellezzo 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.
- Background: PubMed 36801007Gerard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maaike Berbée, MD, PhD principal investigator
Maastro, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maastro applicator in people with Rectal Cancer and Feasibility, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical feasibility of the Maastro boosting technique. (time frame: During treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087718, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.