Rectal CancerNCT07501845
Registry Maastro Applicator
An observational study of Rectal Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 999 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2026to 31 Dec 2034
- Phase
- Observational
- 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
Study population: Patients being treated with the MAASTRO HDR rectal applicator
Who may be able to join
- Age ≥ 18 years.
- Histological proof of rectal cancer, or a strong suspicion after imaging.
- Treatment with MAASTRO HDR rectal applicator
- Informed consent for longitudinal observational data collection.
Who cannot join
- Mentally incompetent patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastro
Maastricht
Ann Claessens, +31 88 44 55 600, ann.claessens@maastro.nl
About this study
Official title: Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
Read the detailed description
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watch-and-wait strategy, which avoids surgery and improves quality of life by preventing complications such as incontinence or the need for a stoma.
Increasing the radiation dose improves the chance of achieving a CR. Endoluminal boost techniques-high-dose-rate (HDR) brachytherapy and contact X-ray radiotherapy (CXRT)-allow a highly localized radiation boost. CXRT has shown higher CR rates than external beam radiotherapy (EBRT) boosts (81% vs. 60%). However, widespread use of endoluminal boosting is limited by the high cost of CXRT equipment and the less favorable dose distribution of HDR brachytherapy.
To overcome these limitations, MAASTRO, in collaboration with Varian Inc., developed a new HDR rectal brachytherapy applicator that delivers a dose profile similar to CXRT. The applicator has received CE certification and is now available for clinical use. A recent clinical trial confirmed that treatment with this applicator is clinically feasible. As a result, MAASTRO HDR treatment is now part of standard care.
To improve understanding of treatment outcomes and optimize future strategies, a prospective observational cohort study has been initiated.This project is designed to continuously include new patients and will provide an ongoing source for multiple future studies
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, HDR Brachy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients being treated with the MAASTRO HDR rectal applicator | Treatment with the MAASTRO HDR rectal applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0
Measured: From enrollment to the end of FU at 10 years
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Measured: During treatment
Duration of the application procedure.
Duration of the application procedure.
Measured: During treatment
Clinical complete response rate up to 5 years after treatment.
Clinical complete response rate up to 5 years after treatment.
Measured: From end of treatment until 5 years after treatment
Rectal toxcity up to 3 year after treatment
Rectal toxicity scored according to CTCAE v. 5 up to 3 years after treatment
Measured: From start treatment until 3 years after the end of treatment
Disease status up to 10 years after treatment
Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment
Measured: from enrollment until 10 years after treatment
Salvage surgery
Salvage surgery rate after treatment.
Measured: From end of treatment until 5 years after treatment
Overall and disease specific survival rate
Overall and disease specific survival rate up to 10 year after treatment.
Measured: from enrollment until 10 years after treatment
Discomfort/pain
Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore
Measured: From baseline up to 2 weeks after last fraction
Toxcity up to 3 year after treatment
Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment
Measured: From start treatment until 3 years after the end of treatment
Genitourinary toxicity up to 3 years after treatment
Genitourinary toxicity scored according to CTCAE v 5 up to 3 years after treatment
Measured: From start treatment until 3 years after the end of treatment
Secondary outcomes (3)
Health status
Separate informed consent will be asked to measure the health status and quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30) , QLQ-CR29 ( EORTC Quality of Life Questionaires ColoRectal 29 and EQ-5D ( EuroQoL-5D)
Measured: From enrollment until 5 years after treatment
Long-term rectal functional outcome
Separate informed consent will be asked to measure the Long-term rectal functional outcome by LARS score (Low Anterior Resection Syndrome - scale 0-42)
Measured: From enrollment until 5 years after treatment
Quality of life questionnaires
Separate informed consent will be asked to measure the quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30).
Measured: From enrollment until 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start23 Mar 2026
- Primary completion1 Apr 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maaike Berbée, MD, PhD, Principal investigator, MaastroBritt Hupkens, MD, PhD, Principal investigator, Maastro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501845
- Sponsor's protocol ID
- Registry Maastro Applicator
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT07501845
- Acronym / sponsor ID
- Registry Maastro Applicator
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, HDR Brachy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 1 Apr 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 30 Mar 2026 (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.
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
Detailed description
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watch-and-wait strategy, which avoids surgery and improves quality of life by preventing complications such as incontinence or the need for a stoma.
Increasing the radiation dose improves the chance of achieving a CR. Endoluminal boost techniques-high-dose-rate (HDR) brachytherapy and contact X-ray radiotherapy (CXRT)-allow a highly localized radiation boost. CXRT has shown higher CR rates than external beam radiotherapy (EBRT) boosts (81% vs. 60%). However, widespread use of endoluminal boosting is limited by the high cost of CXRT equipment and the less favorable dose distribution of HDR brachytherapy.
To overcome these limitations, MAASTRO, in collaboration with Varian Inc., developed a new HDR rectal brachytherapy applicator that delivers a dose profile similar to CXRT. The applicator has received CE certification and is now available for clinical use. A recent clinical trial confirmed that treatment with this applicator is clinically feasible. As a result, MAASTRO HDR treatment is now part of standard care.
To improve understanding of treatment outcomes and optimize future strategies, a prospective observational cohort study has been initiated.This project is designed to continuously include new patients and will provide an ongoing source for multiple future studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients being treated with the MAASTRO HDR rectal applicator | – | –Treatment with the MAASTRO HDR rectal applicator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated with the MAASTRO HDR rectal applicator
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Histological proof of rectal cancer, or a strong suspicion after imaging.
- Treatment with MAASTRO HDR rectal applicator
- Informed consent for longitudinal observational data collection.
Key exclusion criteria (1 listed)
- Mentally incompetent patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
Time frame: From enrollment to the end of FU at 10 years
Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Time frame: During treatment
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Duration of the application procedure.
Time frame: During treatment
Duration of the application procedure.
Clinical complete response rate up to 5 years after treatment.
Time frame: From end of treatment until 5 years after treatment
Clinical complete response rate up to 5 years after treatment.
Rectal toxcity up to 3 year after treatment
Time frame: From start treatment until 3 years after the end of treatment
Rectal toxicity scored according to CTCAE v. 5 up to 3 years after treatment
Disease status up to 10 years after treatment
Time frame: from enrollment until 10 years after treatment
Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment
Salvage surgery
Time frame: From end of treatment until 5 years after treatment
Salvage surgery rate after treatment.
Overall and disease specific survival rate
Time frame: from enrollment until 10 years after treatment
Overall and disease specific survival rate up to 10 year after treatment.
Discomfort/pain
Time frame: From baseline up to 2 weeks after last fraction
Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore
Toxcity up to 3 year after treatment
Time frame: From start treatment until 3 years after the end of treatment
Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment
Genitourinary toxicity up to 3 years after treatment
Time frame: From start treatment until 3 years after the end of treatment
Genitourinary toxicity scored according to CTCAE v 5 up to 3 years after treatment
3 secondary outcomes
Health status
Time frame: From enrollment until 5 years after treatment
Long-term rectal functional outcome
Time frame: From enrollment until 5 years after treatment
Quality of life questionnaires
Time frame: From enrollment until 5 years after treatment
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Maaike Berbée, MD, PhD principal investigator
Maastro
Britt Hupkens, MD, PhD principal investigator
Maastro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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?
Contact Ann Claessens (+31 88 44 55 600, ann.claessens@maastro.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum. (time frame: From enrollment to the end of FU at 10 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.