Rectal CancerPhase 2NCT07402486
A Phase II Prospective Study of Maastro Applicator Brachytherapy for Rectal Cancer
A Phase 2 study testing Rectal HDR brachytherapy via Maastro Applicator in people with Rectal Cancer, run by Siriraj Hospital.
Trial summary
Rectal cancer is a common type of cancer and an important cause of illness and death worldwide. In 2020, cancers of the colon and rectum were the fourth most common cancers globally, and about one third of these cases were rectal cancer. Surgery is the main treatment for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Rectal HDR brachytherapy via Maastro Applicator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
- 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
- Age ≥ 18 years at the time of informed consent Histologically confirmed rectal cancer Any T, N, or M stage, provided the primary rectal lesion is suitable for endorectal HDR brachytherapy Tumor characteristics deemed suitable for treatment with the Maastro applicator (per investigator assessment) Rectal lesion accessible for applicator placement and adequate visualization Adequate organ function to undergo sedation/anesthesia and brachytherapy, as judged by the investigator Ability to comply with study procedures, imaging, and scheduled follow-up Written informed consent obtained prior to study participation
Who cannot join
- Active inflammatory bowel disease with moderate to severe disease activity Uncontrolled proctitis not attributable to tumor involvement Severe anorectal conditions that preclude safe applicator placement (e.g., severe anal stenosis, uncontrolled hemorrhoidal bleeding, severe radiation-induced proctopathy in the target area) Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with safe study participation or interpretation of results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Prospective Clinical Study to Evaluate the Feasibility, Safety, and Early Efficacy of Maastro Applicator High-Dose-Rate Brachytherapy in Selected Patients With Rectal Cancer
Rectal cancer is a common type of cancer and an important cause of illness and death worldwide. In 2020, cancers of the colon and rectum were the fourth most common cancers globally, and about one third of these cases were rectal cancer. Surgery is the main treatment for rectal cancer. In more advanced cases, chemotherapy and external beam radiotherapy are often given before surgery. However, surgery can sometimes result in a permanent stoma (an opening on the abdomen for bowel movements) and carries higher risks of complications, especially in older patients or those with other medical problems. Because of this, there is growing interest in treatment approaches that can control the cancer while avoiding major surgery when possible.
Some studies suggest that in carefully selected patients, rectal cancer can be treated without removing the rectum if the tumor responds well to radiation and chemotherapy. In these patients, survival outcomes may be similar to those who undergo surgery, although the risk of the cancer growing back locally can be slightly higher. This means that careful and long-term follow-up is very important. One of the key challenges with non-surgical treatment is determining how much radiation is needed to completely eliminate the tumor while minimizing side effects.
Read more
Contact X-ray brachytherapy is a type of radiation treatment that delivers a high dose of radiation directly to the tumor using low-energy X-rays. Because the radiation is given very close to the tumor, it can better target the cancer while reducing radiation exposure to surrounding healthy tissues. This technique has been used in Europe for many years and is recommended by international guidelines in selected patients, mainly within research settings. Other forms of brachytherapy using modern radiation sources can achieve similar dose distributions and may also support organ-preserving treatment strategies.
A new medical device called the Maastro applicator has been developed for use with high-dose-rate (HDR) brachytherapy systems. This applicator is designed to deliver radiation in a way that closely mimics low-energy X-ray treatments, while being compatible with widely available HDR brachytherapy equipment. Early technical studies suggest that it can deliver radiation accurately and safely, but its clinical effectiveness and safety in patients with rectal cancer have not yet been fully studied.
This phase II prospective study aims to evaluate the feasibility, safety, and early treatment outcomes of using the Maastro applicator for brachytherapy in patients with rectal cancer. The study will assess how often the tumor completely disappears after treatment, how well the cancer is controlled over time, the side effects of treatment, and how patients' quality of life changes. The results of this study will help determine whether this treatment approach is suitable for wider clinical use and will contribute to improving future treatment options for patients with rectal cancer.
Read the detailed description
This is a single-center, Phase II prospective pilot study designed to evaluate the feasibility, safety, and early clinical outcomes of high-dose-rate (HDR) endorectal brachytherapy delivered using the Maastro applicator in patients with histologically confirmed rectal cancer.
Rectal cancer is commonly treated with surgery, frequently combined with chemotherapy and/or external beam radiotherapy (EBRT) in locally advanced disease. While surgery provides effective local control, it may be associated with substantial morbidity, including the risk of a permanent stoma and functional impairment. These concerns are particularly relevant in older patients or those with significant comorbidities. Consequently, there is increasing interest in organ-preserving strategies for selected patients who achieve a favorable response after non-operative treatment, provided that rigorous surveillance is maintained.
Contact-type local radiation boost approaches, including contact X-ray brachytherapy, deliver a high dose of radiation to the tumor with a steep dose gradient that limits dose to adjacent normal tissues. The Maastro applicator is a novel endorectal applicator developed for use with conventional HDR afterloading systems (Ir-192), intended to achieve a contact-like dose distribution using widely available HDR technology. Although dosimetric and simulation studies support its technical feasibility, prospective clinical evidence remains limited, motivating this Phase II evaluation.
Eligible participants will be adults (≥18 years) with rectal cancer whose tumors are accessible and suitable for endorectal HDR brachytherapy using the Maastro applicator, and who are deemed able to undergo the procedure with sedation/anesthesia as appropriate. Key exclusions include active inflammatory bowel disease (moderate-severe flare) or severe anorectal conditions that preclude safe applicator placement.
Participants will undergo standard baseline assessment per institutional practice, including clinical evaluation and appropriate imaging and/or endoscopic assessment. The Maastro applicator procedure will be performed in a controlled procedural environment. Tumor localization and applicator positioning will be guided by direct endoscopic visualization and transrectal ultrasound (TRUS) as applicable. HDR treatment plans (including applicator selection and relevant planning parameters) will undergo institutional verification and safety checks prior to delivery. Radiation will be delivered via an HDR afterloader through the applicator to the intended target volume. Patients will be observed post-procedure for immediate complications and provided standardized post-procedure instructions.
Participants will be followed at predefined intervals to assess tumor response, toxicity, and patient-reported outcomes. Tumor response will be assessed using clinical evaluation and imaging and/or endoscopy, with biopsy performed when clinically indicated. Adverse events will be captured and graded using CTCAE v5.0, including both acute and late gastrointestinal and genitourinary toxicities. Quality of life will be assessed longitudinally using validated instruments (EORTC QLQ-C30 and EORTC QLQ-CR29). Additional clinical endpoints include local control, regional control, progression-free survival, and overall survival. Exploratory analyses will assess associations between dosimetric parameters and tumor control and/or toxicity.
The primary endpoint is the clinical complete response rate following Maastro applicator HDR brachytherapy. Secondary endpoints include disease control outcomes (local/regional control, progression-free survival, overall survival), incidence of acute and late toxicities, and changes in quality of life over time. The planned sample size is 25 patients, consistent with a Phase II pilot cohort intended to generate early safety and efficacy signals and inform subsequent larger studies and protocol refinement.
- Conditions
- Rectal Cancer
- Being tested
- Rectal HDR brachytherapy via Maastro Applicator
- Keywords
- HDR brachytherapy, Ractal cancer, Contact brachytherapy, MAASTRO applicator
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal HDR brachytherapy via Maastro ApplicatorRadiation
Participants in this study will receive endorectal high-dose-rate (HDR) brachytherapy using the Maastro applicator as part of an organ-preserving treatment approach for rectal cancer.
The Maastro applicator is a specially designed endorectal device intended for use with a standard HDR afterloading brachytherapy system (Ir-192 source). It enables delivery of a high, localized radiation dose directly to the rectal tumor with a steep dose fall-off, thereby minimizing radiation exposure to surrounding normal tissues.
Procedure and delivery The brachytherapy procedure will be performed in a controlled procedural or operating room environment. Prior to treatment, patient identity, informed consent, and procedural safety checks will be confirmed. Local anesthesia and/or sedation will be administered according to institutional practice and patient needs.
A rectoscope will be gently inserted to visualize the rectal lumen. Tumor localization and treatment geometry will be confirmed using direct
| Study group | Role | What they receive |
|---|---|---|
| Rectal HDR brachytherapy | Experimental | The patient will be given HDR brachytherapy via Maastro Applicator either as a monotherapy or boost Receives: Radiation: Rectal HDR brachytherapy via Maastro Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response (cCR) Rate
Clinical complete response is defined as the absence of detectable residual tumor within the treated rectal wall following Maastro applicator HDR brachytherapy, as determined by a combination of clinical examination, endoscopic assessment, and imaging (pelvic MRI), with biopsy performed when clinically indicated. Complete response requires no visible tumor, no ulceration suspicious for malignancy, and no radiologic evidence of residual disease at the treated site.
Measured: Within 6 months after completion of Maastro applicator HDR brachytherapy
Secondary outcomes (7)
Local Control Rate
Local control is defined as the absence of tumor regrowth or persistence within the treated rectal wall or peri-rectal region (i.e., within the high-dose brachytherapy volume), as confirmed by clinical examination, endoscopy, and/or imaging (pelvic MRI), with biopsy performed when clinically indicated. Local failure is defined as biopsy-proven or radiologically evident local recurrence or progression at the treated site.
Measured: Up to 2 years after completion of Maastro applicator HDR brachytherapy
Regional Control Rate
Regional control is defined as the absence of disease recurrence in regional lymphatic drainage areas of the rectum, including mesorectal, internal iliac, presacral, obturator, and external iliac lymph nodes, as assessed by imaging (MRI and/or PET/CT). Regional failure is defined as new or progressive nodal disease within these regions.
Measured: Up to 2 years after completion of Maastro applicator HDR brachytherapy
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the date of initiation of Maastro applicator HDR brachytherapy (or study enrollment) to the first documented evidence of disease progression (local, regional, or distant) or death from any cause, whichever occurs first. Patients alive without progression at last follow-up will be censored at that date.
Measured: Up to 2 years after initiation of Maastro applicator HDR brachytherapy
Overall Survival (OS)
Overall survival is defined as the time from the date of initiation of Maastro applicator HDR brachytherapy (or study enrollment) to death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.
Measured: Up to 2 years after initiation of Maastro applicator HDR brachytherapy
Incidence of Acute and Late Treatment-Related Toxicities
Treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, including acute and late gastrointestinal and genitourinary toxicities. Acute toxicity is defined as events occurring within 90 days of treatment completion, and late toxicity as events occurring thereafter.
Measured: From treatment initiation up to 2 years after completion of Maastro applicator HDR brachytherapy
Quality of Life (QoL)
Quality of life will be evaluated using validated patient-reported outcome instruments, including the EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires. Changes from baseline will be analyzed over time.
Measured: From baseline up to 2 years after completion of Maastro applicator HDR brachytherapy
Correlation of Dosimetric Parameters With Tumor Control and Toxicity
Exploratory analyses will assess the association between dosimetric parameters of Maastro applicator HDR brachytherapy (e.g., prescribed dose, reference point dose, and treated volume) and clinical outcomes, including tumor control and treatment-related toxicities.
Measured: Up to 2 years after completion of Maastro applicator HDR brachytherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiwatchai Sittiwong, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402486
- Sponsor's protocol ID
- Si1005/2568(IRB4)
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Clinical Study to Evaluate the Feasibility, Safety, and Early Efficacy of Maastro Applicator High-Dose-Rate Brachytherapy in Selected Patients With Rectal Cancer
- ClinicalTrials.gov ID
- NCT07402486
- Acronym / sponsor ID
- Si1005/2568(IRB4)
- Conditions
- Rectal Cancer
- Keywords
- HDR brachytherapy, Ractal cancer, Contact brachytherapy, MAASTRO applicator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 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.
Rectal cancer is a common type of cancer and an important cause of illness and death worldwide. In 2020, cancers of the colon and rectum were the fourth most common cancers globally, and about one third of these cases were rectal cancer. Surgery is the main treatment for rectal cancer. In more advanced cases, chemotherapy and external beam radiotherapy are often given before surgery. However, surgery can sometimes result in a permanent stoma (an opening on the abdomen for bowel movements) and carries higher risks of complications, especially in older patients or those with other medical problems. Because of this, there is growing interest in treatment approaches that can control the cancer while avoiding major surgery when possible.
Some studies suggest that in carefully selected patients, rectal cancer can be treated without removing the rectum if the tumor responds well to radiation and chemotherapy. In these patients, survival outcomes may be similar to those who undergo surgery, although the risk of the cancer growing back locally can be slightly higher. This means that careful and long-term follow-up is very important. One of the key challenges with non-surgical treatment is determining how much radiation is needed to completely eliminate the tumor while minimizing side effects.
Contact X-ray brachytherapy is a type of radiation treatment that delivers a high dose of radiation directly to the tumor using low-energy X-rays. Because the radiation is given very close to the tumor, it can better target the cancer while reducing radiation exposure to surrounding healthy tissues. This technique has been used in Europe for many years and is recommended by international guidelines in selected patients, mainly within research settings. Other forms of brachytherapy using modern radiation sources can achieve similar dose distributions and may also support organ-preserving treatment strategies.
A new medical device called the Maastro applicator has been developed for use with high-dose-rate (HDR) brachytherapy systems. This applicator is designed to deliver radiation in a way that closely mimics low-energy X-ray treatments, while being compatible with widely available HDR brachytherapy equipment. Early technical studies suggest that it can deliver radiation accurately and safely, but its clinical effectiveness and safety in patients with rectal cancer have not yet been fully studied.
This phase II prospective study aims to evaluate the feasibility, safety, and early treatment outcomes of using the Maastro applicator for brachytherapy in patients with rectal cancer. The study will assess how often the tumor completely disappears after treatment, how well the cancer is controlled over time, the side effects of treatment, and how patients' quality of life changes. The results of this study will help determine whether this treatment approach is suitable for wider clinical use and will contribute to improving future treatment options for patients with rectal cancer.
Detailed description
This is a single-center, Phase II prospective pilot study designed to evaluate the feasibility, safety, and early clinical outcomes of high-dose-rate (HDR) endorectal brachytherapy delivered using the Maastro applicator in patients with histologically confirmed rectal cancer.
Rectal cancer is commonly treated with surgery, frequently combined with chemotherapy and/or external beam radiotherapy (EBRT) in locally advanced disease. While surgery provides effective local control, it may be associated with substantial morbidity, including the risk of a permanent stoma and functional impairment. These concerns are particularly relevant in older patients or those with significant comorbidities. Consequently, there is increasing interest in organ-preserving strategies for selected patients who achieve a favorable response after non-operative treatment, provided that rigorous surveillance is maintained.
Contact-type local radiation boost approaches, including contact X-ray brachytherapy, deliver a high dose of radiation to the tumor with a steep dose gradient that limits dose to adjacent normal tissues. The Maastro applicator is a novel endorectal applicator developed for use with conventional HDR afterloading systems (Ir-192), intended to achieve a contact-like dose distribution using widely available HDR technology. Although dosimetric and simulation studies support its technical feasibility, prospective clinical evidence remains limited, motivating this Phase II evaluation.
Eligible participants will be adults (≥18 years) with rectal cancer whose tumors are accessible and suitable for endorectal HDR brachytherapy using the Maastro applicator, and who are deemed able to undergo the procedure with sedation/anesthesia as appropriate. Key exclusions include active inflammatory bowel disease (moderate-severe flare) or severe anorectal conditions that preclude safe applicator placement.
Participants will undergo standard baseline assessment per institutional practice, including clinical evaluation and appropriate imaging and/or endoscopic assessment. The Maastro applicator procedure will be performed in a controlled procedural environment. Tumor localization and applicator positioning will be guided by direct endoscopic visualization and transrectal ultrasound (TRUS) as applicable. HDR treatment plans (including applicator selection and relevant planning parameters) will undergo institutional verification and safety checks prior to delivery. Radiation will be delivered via an HDR afterloader through the applicator to the intended target volume. Patients will be observed post-procedure for immediate complications and provided standardized post-procedure instructions.
Participants will be followed at predefined intervals to assess tumor response, toxicity, and patient-reported outcomes. Tumor response will be assessed using clinical evaluation and imaging and/or endoscopy, with biopsy performed when clinically indicated. Adverse events will be captured and graded using CTCAE v5.0, including both acute and late gastrointestinal and genitourinary toxicities. Quality of life will be assessed longitudinally using validated instruments (EORTC QLQ-C30 and EORTC QLQ-CR29). Additional clinical endpoints include local control, regional control, progression-free survival, and overall survival. Exploratory analyses will assess associations between dosimetric parameters and tumor control and/or toxicity.
The primary endpoint is the clinical complete response rate following Maastro applicator HDR brachytherapy. Secondary endpoints include disease control outcomes (local/regional control, progression-free survival, overall survival), incidence of acute and late toxicities, and changes in quality of life over time. The planned sample size is 25 patients, consistent with a Phase II pilot cohort intended to generate early safety and efficacy signals and inform subsequent larger studies and protocol refinement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal HDR brachytherapy | Experimental | Radiation: Rectal HDR brachytherapy via Maastro ApplicatorThe patient will be given HDR brachytherapy via Maastro Applicator either as a monotherapy or boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years at the time of informed consent Histologically confirmed rectal cancer Any T, N, or M stage, provided the primary rectal lesion is suitable for endorectal HDR brachytherapy Tumor characteristics deemed suitable for treatment with the Maastro applicator (per investigator assessment) Rectal lesion accessible for applicator placement and adequate visualization Adequate organ function to undergo sedation/anesthesia and brachytherapy, as judged by the investigator Ability to comply with study procedures, imaging, and scheduled follow-up Written informed consent obtained prior to study participation
Key exclusion criteria (1 listed)
- Active inflammatory bowel disease with moderate to severe disease activity Uncontrolled proctitis not attributable to tumor involvement Severe anorectal conditions that preclude safe applicator placement (e.g., severe anal stenosis, uncontrolled hemorrhoidal bleeding, severe radiation-induced proctopathy in the target area) Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with safe study participation or interpretation of results
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 |
|---|---|---|
| Rectal HDR brachytherapy via Maastro ApplicatorParticipants in this study will receive endorectal high-dose-rate (HDR) brachytherapy using the Maastro applicator as part of an organ-preserving treatment approach for rectal cancer. The Maastro applicator is a specially designed endorectal device intended for use with a standard HDR afterloading brachytherapy system (Ir-192 source). It enables delivery of a high, localized radiation dose directly to the rectal tumor with a steep dose fall-off, thereby minimizing radiation exposure to surrounding normal tissues. Procedure and delivery The brachytherapy procedure will be performed in a controlled procedural or operating room environment. Prior to treatment, patient identity, informed consent, and procedural safety checks will be confirmed. Local anesthesia and/or sedation will be administered according to institutional practice and patient needs. A rectoscope will be gently inserted to visualize the rectal lumen. Tumor localization and treatment geometry will be confirmed using direct | Radiation | Rectal HDR brachytherapy |
Primary outcome
Clinical Complete Response (cCR) Rate
Time frame: Within 6 months after completion of Maastro applicator HDR brachytherapy
Clinical complete response is defined as the absence of detectable residual tumor within the treated rectal wall following Maastro applicator HDR brachytherapy, as determined by a combination of clinical examination, endoscopic assessment, and imaging (pelvic MRI), with biopsy performed when clinically indicated. Complete response requires no visible tumor, no ulceration suspicious for malignancy, and no radiologic evidence of residual disease at the treated site.
7 secondary outcomes
Local Control Rate
Time frame: Up to 2 years after completion of Maastro applicator HDR brachytherapy
Regional Control Rate
Time frame: Up to 2 years after completion of Maastro applicator HDR brachytherapy
Progression-Free Survival (PFS)
Time frame: Up to 2 years after initiation of Maastro applicator HDR brachytherapy
Overall Survival (OS)
Time frame: Up to 2 years after initiation of Maastro applicator HDR brachytherapy
Incidence of Acute and Late Treatment-Related Toxicities
Time frame: From treatment initiation up to 2 years after completion of Maastro applicator HDR brachytherapy
Quality of Life (QoL)
Time frame: From baseline up to 2 years after completion of Maastro applicator HDR brachytherapy
Correlation of Dosimetric Parameters With Tumor Control and Toxicity
Time frame: Up to 2 years after completion of Maastro applicator HDR brachytherapy
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 11 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rectal HDR brachytherapy via Maastro Applicator in people with Rectal Cancer, run by Siriraj Hospital.
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 1 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wiwatchai Sittiwong, MD (66830081877, wiwatchai.sit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Complete Response (cCR) Rate (time frame: Within 6 months after completion of Maastro applicator HDR brachytherapy). 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 11 Feb 2026.