Cervical CancerHYPOCx-iRexNCT07605507
Hypofractionated Whole Pelvic Chemoradiotherapy With iRex Optimization in Cervical Cancer
A study testing Hypofractionated Radiotherapy, Conventional Radiotherapy and Concurrent chemotherapy once a week in people with Cervical Cancer, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
This study is a randomized controlled trial designed to compare hypofractionated whole pelvic radiotherapy with conventional radiotherapy in patients with cervical cancer undergoing concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Hypofractionated Radiotherapy, Conventional Radiotherapy and Concurrent chemotherapy once a week
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jul 2021to 31 Jul 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix
- Staging according to FIGO 2018 and TNM guidelines
- MRI of the pelvis at diagnosis is performed
- MRI, CT, or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
- MRI with the applicator in place at the time of (first) BT will be performed
- GFR ≥ 50 mL/min
- Patient informed consent
Who cannot join
- Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix
- Metastatic disease beyond intervertebral disc L2/3 level
- Previous pelvic or abdominal radiotherapy
- Previous total or subtotal hysterectomy
- Combination of preoperative radiotherapy with surgery
Show all 11Show fewer
- Patients receiving BT only
- Patients receiving EBRT only
- Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2).
- Contra-indications to MRI
- Contra-indications to BT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical (Cx) Cancer With "Indirect Excess Dose Volume Ratio (iRex)" - Optimized Image Guided Adaptive Brachytherapy (HYPOCx-iRex Trial) : A Phase II Non-inferiority Randomized Controlled Trial
This study is a randomized controlled trial designed to compare hypofractionated whole pelvic radiotherapy with conventional radiotherapy in patients with cervical cancer undergoing concurrent chemoradiotherapy.
Hypofractionated radiotherapy delivers a higher dose per treatment over a shorter overall treatment time, which may reduce the number of hospital visits and improve treatment convenience for patients. Conventional radiotherapy requires more treatment sessions over a longer period.
Read more
The purpose of this study is to evaluate whether hypofractionated radiotherapy is as safe and effective as conventional radiotherapy. The primary outcomes focus on treatment-related toxicity, while secondary outcomes include tumor response, survival outcomes, quality of life, and treatment-related factors.
In addition, this study will evaluate a novel planning approach called the indirect excess dose volume ratio (iRex) to optimize brachytherapy planning and potentially reduce radiation-related side effects.
Read the detailed description
Cervical cancer remains a significant global health burden, particularly in low- and middle-income countries. Standard treatment for locally advanced cervical cancer consists of conventional fractionated radiotherapy combined with concurrent chemotherapy, followed by brachytherapy. However, conventional radiotherapy requires prolonged treatment duration, which may negatively impact patient compliance, healthcare resource utilization, and treatment outcomes.
Hypofractionated radiotherapy delivers a higher dose per fraction while maintaining a comparable total biological dose, thereby reducing the overall treatment time. Shortening treatment duration may improve tumor control based on radiobiological principles and reduce patient burden, including travel and treatment-related costs.
Previous studies suggest that hypofractionated radiotherapy may provide comparable oncologic outcomes to conventional radiotherapy, with acceptable toxicity profiles. However, high-quality randomized evidence remains limited, particularly using modern radiotherapy techniques such as intensity-modulated radiotherapy (IMRT) and image-guided adaptive brachytherapy (IGABT).
This study is a Phase II randomized controlled trial designed to evaluate the safety and feasibility of hypofractionated whole pelvic radiotherapy compared with conventional fractionation. Patients will be randomized to receive either hypofractionated or conventional external beam radiotherapy, both combined with concurrent chemotherapy and followed by brachytherapy.
In addition, this study incorporates a novel dosimetric parameter, the indirect excess dose volume ratio (iRex), to optimize brachytherapy planning. The use of iRex in combination with standard dose constraints may improve spatial dose control and reduce radiation-induced toxicity.
The primary objective is to assess treatment-related toxicity, while secondary objectives include tumor response, survival outcomes, quality of life, dosimetric parameters, and cost-effectiveness. This study aims to provide evidence supporting a shorter, more efficient radiotherapy regimen without compromising safety or efficacy.
- Conditions
- Cervical Cancer
- Being tested
- Hypofractionated Radiotherapy, Conventional Radiotherapy, Concurrent chemotherapy once a week, Image-guided Adaptive Brachytherapy, iReX Optimization
- Keywords
- Cervical Cancer, Hypofractionated Radiotherapy, Conventional Radiotherapy, Whole Pelvic Radiotherapy, Chemoradiotherapy, Brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiotherapyRadiation
Whole pelvic radiotherapy delivered using hypofractionation (2.2 Gy per fraction over 20 fractions) with IMRT.
Conventional RadiotherapyRadiation
Whole pelvic radiotherapy delivered using conventional fractionation (1.8 Gy per fraction over 25 fractions) with IMRT.
Concurrent chemotherapy once a weekDrug
Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles.
Image-guided Adaptive BrachytherapyProcedure or surgery
Image-guided adaptive brachytherapy delivered following external beam radiotherapy.
iReX OptimizationProcedure or surgery
Brachytherapy treatment planning optimized using iReX in addition to standard D2cc constraints.
Standard D2cc PlanningProcedure or surgery
Conventional brachytherapy treatment planning using standard D2cc constraints without iReX optimization.
| Study group | Role | What they receive |
|---|---|---|
| HYPO + iREX | Experimental | Participants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex in addition to standard D2cc constraints. Receives: Radiation: Hypofractionated Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: iReX Optimization |
| HYPO + Standard Planning | Experimental | Participants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard D2cc constraints without iRex optimization. Receives: Radiation: Hypofractionated Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: Standard D2cc Planning |
| CVRT + iREX | Active comparator | Participants receive conventional fractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex. Receives: Radiation: Conventional Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: iReX Optimization |
| CVRT + Standard Planning | Active comparator | Participants receive conventional fractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard planning without iRex. Receives: Radiation: Conventional Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: Standard D2cc Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Treatment-Related Toxicity
Incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up after treatment, assessed using CTCAE version 5.0.
Measured: During treatment and up to 3 months after completion of radiotherapy
Incidence of Late (Chronic) Treatment-Related Toxicity
Incidence of late (chronic) treatment-related toxicity assessed at 6 and 12 months, and at 3 and 5 years after treatment using CTCAE version 5.0.
Measured: From 6 months up to 5 years after completion of radiotherapy
Secondary outcomes (12)
Tumor Response Rate
Tumor response rate assessed after external beam radiotherapy and at 3-, 6-, and 12-month follow-up.
Measured: Up to 12 months after completion of radiotherapy
Quality of Life Assessed by EQ-5D-5L
Patient-reported quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) during treatment and at 1-, 3-, 6-, and 12-month, and 3- and 5-year follow-up.
The EQ-5D-5L descriptive system assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression across 5 levels of severity. The EQ Visual Analog Scale (EQ-VAS) ranges from 0 to 100, with higher scores indicating better perceived health status.
Measured: During treatment and up to 5 years after completion of radiotherapy
Local Recurrence-free Survival
Time from completion of radiotherapy to local tumor recurrence.
Measured: At 3 and 5 years after completion of radiotherapy
Nodal Recurrence-free Survival
Time from completion of radiotherapy to nodal recurrence.
Measured: At 3 and 5 years after completion of radiotherapy.
Distant Metastasis-free Survival
Time from completion of radiotherapy to distant metastasis.
Measured: At 3 and 5 years after completion of radiotherapy.
Disease-specific Survival
Time from completion of radiotherapy to death due to cervical cancer.
Measured: At 3 and 5 years after completion of radiotherapy.
Overall Survival
Time from completion of radiotherapy to death from any cause.
Measured: At 3 and 5 years after completion of radiotherapy.
Correlation of Dosimetric Parameters With Tumor Control and Toxicity
Exploratory analyses will assess the correlation between dosimetric parameters from brachytherapy treatment planning, including dose-volume histogram (DVH) metrics and iRex optimization values, and clinical outcomes, including local tumor control and incidence of treatment-related gastrointestinal and genitourinary toxicities assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: During treatment and follow-up up to 5 years after completion of radiotherapy.
High-risk Clinical Target Volume D90 Comparison Between iRex-oriented and Conventional Brachytherapy Planning
Comparison of high-risk clinical target volume (HR-CTV) D90 dose between iRex-oriented optimization and conventional brachytherapy planning.
Measured: From treatment initiation through completion of brachytherapy treatment, an average of 4 weeks.
Number of Brachytherapy Fractions Achieving Successful iRex Optimization
Number and percentage of brachytherapy fractions achieving successful iRex-oriented dose optimization according to predefined planning objectives.
Measured: From treatment initiation through completion of brachytherapy treatment, an average of 4 weeks.
Dose-Response Relationship Between iRex and Toxicity
Evaluation of the relationship between iRex values and treatment-related toxicity.
Measured: During follow-up up to 5 years
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
Cost and utility data will be used to evaluate cost-effectiveness by calculating the incremental cost-effectiveness ratio (ICER) between hypofractionated and conventional radiotherapy. Uncertainty analyses will be performed using oneway sensitivity analysis, probabilistic sensitivity analysis, and threshold analysis.
Measured: During treatment and follow-up up to 5 years after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 Jul 2021
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT07605507
- Sponsor's protocol ID
- Si 149/2564(IRB3)
- Acronym
- HYPOCx-iRex
- Status last verified
- May 2026
- First submitted
- 16 Apr 2026
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical (Cx) Cancer With "Indirect Excess Dose Volume Ratio (iRex)" - Optimized Image Guided Adaptive Brachytherapy (HYPOCx-iRex Trial) : A Phase II Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07605507
- Acronym / sponsor ID
- HYPOCx-iRex / Si 149/2564(IRB3)
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Hypofractionated Radiotherapy, Conventional Radiotherapy, Whole Pelvic Radiotherapy, Chemoradiotherapy, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 May 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 study is a randomized controlled trial designed to compare hypofractionated whole pelvic radiotherapy with conventional radiotherapy in patients with cervical cancer undergoing concurrent chemoradiotherapy.
Hypofractionated radiotherapy delivers a higher dose per treatment over a shorter overall treatment time, which may reduce the number of hospital visits and improve treatment convenience for patients. Conventional radiotherapy requires more treatment sessions over a longer period.
The purpose of this study is to evaluate whether hypofractionated radiotherapy is as safe and effective as conventional radiotherapy. The primary outcomes focus on treatment-related toxicity, while secondary outcomes include tumor response, survival outcomes, quality of life, and treatment-related factors.
In addition, this study will evaluate a novel planning approach called the indirect excess dose volume ratio (iRex) to optimize brachytherapy planning and potentially reduce radiation-related side effects.
Detailed description
Cervical cancer remains a significant global health burden, particularly in low- and middle-income countries. Standard treatment for locally advanced cervical cancer consists of conventional fractionated radiotherapy combined with concurrent chemotherapy, followed by brachytherapy. However, conventional radiotherapy requires prolonged treatment duration, which may negatively impact patient compliance, healthcare resource utilization, and treatment outcomes.
Hypofractionated radiotherapy delivers a higher dose per fraction while maintaining a comparable total biological dose, thereby reducing the overall treatment time. Shortening treatment duration may improve tumor control based on radiobiological principles and reduce patient burden, including travel and treatment-related costs.
Previous studies suggest that hypofractionated radiotherapy may provide comparable oncologic outcomes to conventional radiotherapy, with acceptable toxicity profiles. However, high-quality randomized evidence remains limited, particularly using modern radiotherapy techniques such as intensity-modulated radiotherapy (IMRT) and image-guided adaptive brachytherapy (IGABT).
This study is a Phase II randomized controlled trial designed to evaluate the safety and feasibility of hypofractionated whole pelvic radiotherapy compared with conventional fractionation. Patients will be randomized to receive either hypofractionated or conventional external beam radiotherapy, both combined with concurrent chemotherapy and followed by brachytherapy.
In addition, this study incorporates a novel dosimetric parameter, the indirect excess dose volume ratio (iRex), to optimize brachytherapy planning. The use of iRex in combination with standard dose constraints may improve spatial dose control and reduce radiation-induced toxicity.
The primary objective is to assess treatment-related toxicity, while secondary objectives include tumor response, survival outcomes, quality of life, dosimetric parameters, and cost-effectiveness. This study aims to provide evidence supporting a shorter, more efficient radiotherapy regimen without compromising safety or efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HYPO + iREX | Experimental | Radiation: Hypofractionated Radiotherapy, Drug: Concurrent chemotherapy once a week, Procedure: Image-guided Adaptive Brachytherapy, Procedure: iReX OptimizationParticipants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex in addition to standard D2cc constraints. |
| HYPO + Standard Planning | Experimental | Radiation: Hypofractionated Radiotherapy, Drug: Concurrent chemotherapy once a week, Procedure: Image-guided Adaptive Brachytherapy, Procedure: Standard D2cc PlanningParticipants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard D2cc constraints without iRex optimization. |
| CVRT + iREX | Active comparator | Radiation: Conventional Radiotherapy, Drug: Concurrent chemotherapy once a week, Procedure: Image-guided Adaptive Brachytherapy, Procedure: iReX OptimizationParticipants receive conventional fractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex. |
| CVRT + Standard Planning | Active comparator | Radiation: Conventional Radiotherapy, Drug: Concurrent chemotherapy once a week, Procedure: Image-guided Adaptive Brachytherapy, Procedure: Standard D2cc PlanningParticipants receive conventional fractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard planning without iRex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix
- Staging according to FIGO 2018 and TNM guidelines
- MRI of the pelvis at diagnosis is performed
- MRI, CT, or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
Key exclusion criteria (11 listed)
- Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix
- Metastatic disease beyond intervertebral disc L2/3 level
- Previous pelvic or abdominal radiotherapy
- Previous total or subtotal hysterectomy
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 |
|---|---|---|
| Hypofractionated RadiotherapyWhole pelvic radiotherapy delivered using hypofractionation (2.2 Gy per fraction over 20 fractions) with IMRT. | Radiation | HYPO + Standard Planning, HYPO + iREX |
| Conventional RadiotherapyWhole pelvic radiotherapy delivered using conventional fractionation (1.8 Gy per fraction over 25 fractions) with IMRT. | Radiation | CVRT + Standard Planning, CVRT + iREX |
| Concurrent chemotherapy once a weekCisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles. | Drug | CVRT + Standard Planning, CVRT + iREX, HYPO + Standard Planning, HYPO + iREX |
| Image-guided Adaptive BrachytherapyImage-guided adaptive brachytherapy delivered following external beam radiotherapy. | Procedure or surgery | CVRT + Standard Planning, CVRT + iREX, HYPO + Standard Planning, HYPO + iREX |
| iReX OptimizationBrachytherapy treatment planning optimized using iReX in addition to standard D2cc constraints. | Procedure or surgery | CVRT + iREX, HYPO + iREX |
| Standard D2cc PlanningConventional brachytherapy treatment planning using standard D2cc constraints without iReX optimization. | Procedure or surgery | CVRT + Standard Planning, HYPO + Standard Planning |
Primary outcome
Incidence of Acute Treatment-Related Toxicity
Time frame: During treatment and up to 3 months after completion of radiotherapy
Incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up after treatment, assessed using CTCAE version 5.0.
Incidence of Late (Chronic) Treatment-Related Toxicity
Time frame: From 6 months up to 5 years after completion of radiotherapy
Incidence of late (chronic) treatment-related toxicity assessed at 6 and 12 months, and at 3 and 5 years after treatment using CTCAE version 5.0.
12 secondary outcomes
Tumor Response Rate
Time frame: Up to 12 months after completion of radiotherapy
Quality of Life Assessed by EQ-5D-5L
Time frame: During treatment and up to 5 years after completion of radiotherapy
Local Recurrence-free Survival
Time frame: At 3 and 5 years after completion of radiotherapy
Nodal Recurrence-free Survival
Time frame: At 3 and 5 years after completion of radiotherapy.
Distant Metastasis-free Survival
Time frame: At 3 and 5 years after completion of radiotherapy.
Disease-specific Survival
Time frame: At 3 and 5 years after completion of radiotherapy.
Overall Survival
Time frame: At 3 and 5 years after completion of radiotherapy.
Correlation of Dosimetric Parameters With Tumor Control and Toxicity
Time frame: During treatment and follow-up up to 5 years after completion of radiotherapy.
High-risk Clinical Target Volume D90 Comparison Between iRex-oriented and Conventional Brachytherapy Planning
Time frame: From treatment initiation through completion of brachytherapy treatment, an average of 4 weeks.
Number of Brachytherapy Fractions Achieving Successful iRex Optimization
Time frame: From treatment initiation through completion of brachytherapy treatment, an average of 4 weeks.
Dose-Response Relationship Between iRex and Toxicity
Time frame: During follow-up up to 5 years
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
Time frame: During treatment and follow-up up to 5 years after completion of radiotherapy.
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 26 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiotherapy, Conventional Radiotherapy and Concurrent chemotherapy once a week in people with Cervical Cancer, run by Siriraj Hospital at 1 site in Thailand.
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 8 inclusion and 11 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 26 May 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 Thailand. 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?
Incidence of Acute Treatment-Related Toxicity (time frame: During treatment and up to 3 months after completion of radiotherapy). The study lists 2 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 26 May 2026.