Cervival CancerPhase 3HYPOCxNCT07709650
Hypofractionated Chemoradiotherapy for Cervical Cancer
A Phase 3 study testing Hypofractionated Chemoradiotherapy, Conventional Chemoradiotherapy and Concurrent chemotherapy in people with Cervival Cancer, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervival Cancer
- What is being tested?
- Hypofractionated Chemoradiotherapy, Conventional Chemoradiotherapy and Concurrent chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteThailand
- Study dates
- 3 Aug 2026to Jun 2033
- Phase
- Phase 3
- 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
- Locally advanced staging according to FIGO 2018 and TNM guidelines (Stage IA1-IVA)
- 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. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Tissana Prasartseree, MD, 66625246101, tissana.p@gmail.com
About this study
Official title: HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical Cancer (HYPOCx Trial): A Phase III Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on encouraging safety and efficacy outcomes from our Phase II HYPOCx-iRex trial (TCTR20210812003), this study will provide data for a critical evidence gap regarding the safety, feasibility, and oncologic efficacy of hypofractionated radiotherapy, including extended-field para-aortic treatment, delivered with concurrent chemotherapy.
The main questions it aims to answer are:
Read more
- Does hypofractionated chemoradiotherapy achieve superior nodal control compared to conventional chemoradiotherapy?
- Does hypofractionated chemoradiotherapy achieve superior overall survival compared to conventional chemoradiotherapy?
Researchers will compare patients receiving hypofractionated external beam radiotherapy to those receiving conventional fractionation to evaluate if the shortened hypofractionated schedule provides comparable disease control, acceptable toxicity, improved quality of life, and cost-effectiveness.
Participants will:
- Be randomized to receive either hypofractionated external beam radiotherapy or conventional fractionation radiotherapy, both delivered using modern IMRT/VMAT techniques targeting either the whole pelvis or extended fields (including para-aortic lymph nodes).
- Receive concurrent platinum-based chemotherapy during external beam radiation.
- Complete image-guided adaptive brachytherapy following external beam radiotherapy.
- Attend scheduled follow-up visits to evaluate tumor response, disease control, treatment-related toxicities, quality of life, and survival outcomes.
Read the detailed description
Cervical cancer remains a major contributor to cancer-related morbidity and mortality among women in low- and middle-income countries, including Thailand. Despite advancements in screening programs and human papillomavirus (HPV) vaccination, a substantial proportion of patients present with locally advanced disease necessitating definitive concurrent chemoradiotherapy.
The established standard of care for locally advanced cervical cancer consists of conventionally fractionated external beam radiotherapy (45 to 50.4 Gy delivered in 25 to 28 fractions) administered concurrently with platinum-based chemotherapy, followed by image-guided adaptive brachytherapy. However, this extended 5-to-7-week regimen imposes significant logistical and financial burdens on patients and healthcare infrastructure, contributing to prolonged overall treatment times, institutional capacity constraints, and restricted access to radiation oncology services. Although hypofractionated radiotherapy has established efficacy and safety in the treatment of breast, prostate, and rectal malignancies, high-level prospective evidence validating its application alongside concurrent chemotherapy in cervical cancer, particularly in the setting of extended-field irradiation, remains limited due to concerns regarding exacerbated gastrointestinal and hematologic toxicities.
To address these therapeutic constraints of conventional fractionation, our group conducted the Phase II HYPOCx-iRex trial (TCTR20210812003). Findings from the HYPOCx-iRex study provided essential clinical proof-of-concept, demonstrating that hypofractionated chemoradiotherapy delivered via advanced delivery techniques, such as IMRT/VMAT with adaptive brachytherapy, achieves acceptable gastrointestinal toxicity rates and promising short-term disease control relative to historical conventional benchmarks.
Building upon the foundation of the Phase II HYPOCx-iRex trial (TCTR20210812003), this multicenter Phase III randomized controlled superiority trial is designed to evaluate this hypofractionated paradigm. Crucially, this trial seeks to address the persistent lack of prospective evidence regarding the safety, feasibility, and oncologic efficacy of hypofractionated extended-field radiotherapy combined with concurrent platinum-based chemotherapy.
In this trial, patients with early-stage node-positive or locally advanced cervical cancer will be randomized to receive either hypofractionated or conventionally fractionated external beam radiotherapy, both administered using high-precision IMRT/VMAT techniques with concurrent chemotherapy and image-guided adaptive brachytherapy. The primary endpoints are nodal control and overall survival. Secondary endpoints encompass tumor response rate, locoregional control, event-free survival, acute and late toxicities, quality of life, and health economic cost-effectiveness. The trial's findings are anticipated to generate high-level clinical evidence capable of demonstrating superior therapeutic and operational value, mitigating treatment delays, and establishing a more accessible, resource-efficient treatment standard.
- Conditions
- Cervival Cancer
- Being tested
- Hypofractionated Chemoradiotherapy, Conventional Chemoradiotherapy, Concurrent chemotherapy
- 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 ChemoradiotherapyRadiation
Whole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 44 Gy in 20 fractions (2.2 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols.
Conventional ChemoradiotherapyRadiation
Whole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 45 Gy in 25 fractions (1.8 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols.
Concurrent chemotherapyDrug
Concurrent chemotherapy once a week Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Chemoradiotherapy (CONV) | Active comparator | Participants assigned to this arm will receive conventionally fractionated whole pelvic external beam radiotherapy (45 Gy in 25 fractions or equivalent institutional standard) using IMRT/VMAT techniques, administered concurrently with weekly platinum-based chemotherapy, followed by image-guided adaptive brachytherapy according to institutional protocols. Receives: Radiation: Conventional Chemoradiotherapy; Drug: Concurrent chemotherapy |
| Hypofractionated Chemoradiotherapy (HYPO) | Experimental | Participants assigned to this arm will receive hypofractionated whole pelvic external beam radiotherapy (44 Gy in 20 fractions) using IMRT/VMAT techniques, administered concurrently with weekly platinum-based chemotherapy, followed by image-guided adaptive brachytherapy according to institutional protocols. Receives: Radiation: Hypofractionated Chemoradiotherapy; Drug: Concurrent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodal Recurrence-free Survival
Time from completion of radiotherapy to the first occurrence of nodal recurrence
Measured: Up to 5 years after completion of radiotherapy
Overall Survival (OS)
Time from completion of radiotherapy to death from any cause.
Measured: Up to 5 years after completion of radiotherapy
Secondary outcomes (11)
Tumor Response Rate
Tumor response rate assessed after external beam radiotherapy and at 3-, 6-, and 12-month follow-up after treatment.
Measured: Up to 12 months 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
Pelvic Recurrence-free Survival
Time from completion of radiotherapy to pelvic recurrence.
Measured: At 3 and 5 years after completion of radiotherapy
Para-aortic Recurrence-free Survival
Time from completion of radiotherapy to para-aortic recurrence.
Measured: At 3 and 5 years after completion of radiotherapy
Locoregional Recurrence-free Survival
Time from completion of radiotherapy to local, pelvic, or para-aortic 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
Event-free Survival
Time from completion of radiotherapy to disease recurrence, disease progression, initiation of salvage treatment, or death from any cause
Measured: Up to 5 years after completion of radiotherapy
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
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.
Measured: During treatment and up to 5 years after completion of radiotherapy
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 posted16 Jul 2026
- Study start3 Aug 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervival 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either hypofractionated whole pelvic concurrent chemoradiotherapy or conventional fractionated concurrent chemoradiotherapy. Both treatment groups will receive IMRT/VMAT-based external beam radiotherapy with concurrent platinum-based chemotherapy followed by image-guided adaptive brachytherapy. Outcomes will be compared between the two parallel groups throughout the study follow-up period.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Principal investigator, Tissana Prasartseree, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709650
- Sponsor's protocol ID
- Si 577/2569(IRB1)
- Acronym
- HYPOCx
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical Cancer (HYPOCx Trial): A Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07709650
- Acronym / sponsor ID
- HYPOCx / Si 577/2569(IRB1)
- Conditions
- Cervival Cancer
- Keywords
- Cervical Cancer, Hypofractionated Radiotherapy, Conventional Radiotherapy, Whole Pelvic Radiotherapy, Chemoradiotherapy, Brachytherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 16 Jul 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.
The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on encouraging safety and efficacy outcomes from our Phase II HYPOCx-iRex trial (TCTR20210812003), this study will provide data for a critical evidence gap regarding the safety, feasibility, and oncologic efficacy of hypofractionated radiotherapy, including extended-field para-aortic treatment, delivered with concurrent chemotherapy.
The main questions it aims to answer are:
- Does hypofractionated chemoradiotherapy achieve superior nodal control compared to conventional chemoradiotherapy?
- Does hypofractionated chemoradiotherapy achieve superior overall survival compared to conventional chemoradiotherapy?
Researchers will compare patients receiving hypofractionated external beam radiotherapy to those receiving conventional fractionation to evaluate if the shortened hypofractionated schedule provides comparable disease control, acceptable toxicity, improved quality of life, and cost-effectiveness.
Participants will:
- Be randomized to receive either hypofractionated external beam radiotherapy or conventional fractionation radiotherapy, both delivered using modern IMRT/VMAT techniques targeting either the whole pelvis or extended fields (including para-aortic lymph nodes).
- Receive concurrent platinum-based chemotherapy during external beam radiation.
- Complete image-guided adaptive brachytherapy following external beam radiotherapy.
- Attend scheduled follow-up visits to evaluate tumor response, disease control, treatment-related toxicities, quality of life, and survival outcomes.
Detailed description
Cervical cancer remains a major contributor to cancer-related morbidity and mortality among women in low- and middle-income countries, including Thailand. Despite advancements in screening programs and human papillomavirus (HPV) vaccination, a substantial proportion of patients present with locally advanced disease necessitating definitive concurrent chemoradiotherapy.
The established standard of care for locally advanced cervical cancer consists of conventionally fractionated external beam radiotherapy (45 to 50.4 Gy delivered in 25 to 28 fractions) administered concurrently with platinum-based chemotherapy, followed by image-guided adaptive brachytherapy. However, this extended 5-to-7-week regimen imposes significant logistical and financial burdens on patients and healthcare infrastructure, contributing to prolonged overall treatment times, institutional capacity constraints, and restricted access to radiation oncology services. Although hypofractionated radiotherapy has established efficacy and safety in the treatment of breast, prostate, and rectal malignancies, high-level prospective evidence validating its application alongside concurrent chemotherapy in cervical cancer, particularly in the setting of extended-field irradiation, remains limited due to concerns regarding exacerbated gastrointestinal and hematologic toxicities.
To address these therapeutic constraints of conventional fractionation, our group conducted the Phase II HYPOCx-iRex trial (TCTR20210812003). Findings from the HYPOCx-iRex study provided essential clinical proof-of-concept, demonstrating that hypofractionated chemoradiotherapy delivered via advanced delivery techniques, such as IMRT/VMAT with adaptive brachytherapy, achieves acceptable gastrointestinal toxicity rates and promising short-term disease control relative to historical conventional benchmarks.
Building upon the foundation of the Phase II HYPOCx-iRex trial (TCTR20210812003), this multicenter Phase III randomized controlled superiority trial is designed to evaluate this hypofractionated paradigm. Crucially, this trial seeks to address the persistent lack of prospective evidence regarding the safety, feasibility, and oncologic efficacy of hypofractionated extended-field radiotherapy combined with concurrent platinum-based chemotherapy.
In this trial, patients with early-stage node-positive or locally advanced cervical cancer will be randomized to receive either hypofractionated or conventionally fractionated external beam radiotherapy, both administered using high-precision IMRT/VMAT techniques with concurrent chemotherapy and image-guided adaptive brachytherapy. The primary endpoints are nodal control and overall survival. Secondary endpoints encompass tumor response rate, locoregional control, event-free survival, acute and late toxicities, quality of life, and health economic cost-effectiveness. The trial's findings are anticipated to generate high-level clinical evidence capable of demonstrating superior therapeutic and operational value, mitigating treatment delays, and establishing a more accessible, resource-efficient treatment standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either hypofractionated whole pelvic concurrent chemoradiotherapy or conventional fractionated concurrent chemoradiotherapy. Both treatment groups will receive IMRT/VMAT-based external beam radiotherapy with concurrent platinum-based chemotherapy followed by image-guided adaptive brachytherapy. Outcomes will be compared between the two parallel groups throughout the study follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Conventional Chemoradiotherapy (CONV) | Active comparator | Radiation: Conventional Chemoradiotherapy, Drug: Concurrent chemotherapyParticipants assigned to this arm will receive conventionally fractionated whole pelvic external beam radiotherapy (45 Gy in 25 fractions or equivalent institutional standard) using IMRT/VMAT techniques, administered concurrently with weekly platinum-based chemotherapy, followed by image-guided adaptive brachytherapy according to institutional protocols. |
| Hypofractionated Chemoradiotherapy (HYPO) | Experimental | Radiation: Hypofractionated Chemoradiotherapy, Drug: Concurrent chemotherapyParticipants assigned to this arm will receive hypofractionated whole pelvic external beam radiotherapy (44 Gy in 20 fractions) using IMRT/VMAT techniques, administered concurrently with weekly platinum-based chemotherapy, followed by image-guided adaptive brachytherapy according to institutional protocols. |
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
- Locally advanced staging according to FIGO 2018 and TNM guidelines (Stage IA1-IVA)
- 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 ChemoradiotherapyWhole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 44 Gy in 20 fractions (2.2 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols. | Radiation | Hypofractionated Chemoradiotherapy (HYPO) |
| Conventional ChemoradiotherapyWhole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 45 Gy in 25 fractions (1.8 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols. | Radiation | Conventional Chemoradiotherapy (CONV) |
| Concurrent chemotherapyConcurrent chemotherapy once a week Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles. | Drug | Conventional Chemoradiotherapy (CONV), Hypofractionated Chemoradiotherapy (HYPO) |
Primary outcome
Nodal Recurrence-free Survival
Time frame: Up to 5 years after completion of radiotherapy
Time from completion of radiotherapy to the first occurrence of nodal recurrence
Overall Survival (OS)
Time frame: Up to 5 years after completion of radiotherapy
Time from completion of radiotherapy to death from any cause.
11 secondary outcomes
Tumor Response Rate
Time frame: Up to 12 months after completion of radiotherapy
Local Recurrence-free Survival
Time frame: At 3 and 5 years after completion of radiotherapy
Pelvic Recurrence-free Survival
Time frame: At 3 and 5 years after completion of radiotherapy
Para-aortic Recurrence-free Survival
Time frame: At 3 and 5 years after completion of radiotherapy
Locoregional 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
Event-free Survival
Time frame: Up to 5 years after completion of radiotherapy
Incidence of Acute Treatment-related Toxicity
Time frame: During treatment and up to 3 months after completion of radiotherapy
Incidence of Late (Chronic) Treatment-related Toxicity
Time frame: From 6 months up to 5 years 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
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypofractionated Chemoradiotherapy, Conventional Chemoradiotherapy and Concurrent chemotherapy in people with Cervival Cancer, run by Mahidol University 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: looking for participants now, as of the sponsor's last update on 24 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tissana Prasartseree, MD (66625246101, tissana.p@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodal Recurrence-free Survival (time frame: Up to 5 years 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 24 Aug 2026.