Cervical NeoplasmNCT05994300
Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer
A study testing Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy in people with Cervical Neoplasm and Adaptive Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect
- What is being tested?
- Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2023to 31 Dec 2025
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years to 70 years
- FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers
- FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain
- Histology: squamous
- Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
- Brachytherapy candidate
- Functional State Eastern Cooperative Oncology Group (ECOG)0-2
Who cannot join
- Patients who had chemotherapeutic, surgical and/or radiotherapy treatment
- FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
- FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes
- Previous pelvic or abdominal radiotherapy
- Patient unable to undergo MR scan
- ECOG performance status greater than 2
- Not a cisplatin candidate
- Other factors that contraindicate experimental therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
Read the detailed description
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17 fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.
- Being tested
- Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
- Keywords
- moderately hypofractionated radiotherapy, adaptive radiotherapy, cervical cancer.
- Medical subject headings
- Uterine Cervical Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) BrachytherapyRadiation
Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy
Drug: Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Experimental | Not described Receives: Radiation: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
Measured: 3 months
Secondary outcomes (7)
Late toxicity
Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Measured: 3 years
Response evaluation evaluated with RECIST 1.1
Evaluated with RECIST 1.1
Measured: One month after treatment
Disease-free survival
Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up.
Measured: 3 years
Overall survival
Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.
Measured: 3 years
Quality of life (QoL)
QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality.
Measured: 3 years
Quality of life (QoL)
QoL will evaluated by the EORTC QLQ-C-30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."
Measured: 3 years
Assessment of tumor regression throughout EBRT
To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start19 Sep 2023
- Primary completion22 Jul 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasmStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuquan Zhang, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994300
- Sponsor's protocol ID
- MHARTCC-Trial
- Status last verified
- May 2025
- First submitted
- 5 Aug 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of the patients
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT05994300
- Acronym / sponsor ID
- MHARTCC-Trial
- Keywords
- moderately hypofractionated radiotherapy, adaptive radiotherapy, cervical cancer.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
Detailed description
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17 fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Experimental | Radiation: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years to 70 years
- FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers
- FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain
- Histology: squamous
- Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
Key exclusion criteria (8 listed)
- Patients who had chemotherapeutic, surgical and/or radiotherapy treatment
- FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
- FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes
- Previous pelvic or abdominal radiotherapy
- Patient unable to undergo MR scan
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 |
|---|---|---|
| Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) BrachytherapyExperimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy Drug: Concurrent Chemotherapy Weekly cisplatin 40 mg/m2 | Radiation | Moderately Hypofractionated Adaptive Radiotherapy |
Primary outcome
Acute toxicity
Time frame: 3 months
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
7 secondary outcomes
Late toxicity
Time frame: 3 years
Response evaluation evaluated with RECIST 1.1
Time frame: One month after treatment
Disease-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Quality of life (QoL)
Time frame: 3 years
Quality of life (QoL)
Time frame: 3 years
Assessment of tumor regression throughout EBRT
Time frame: 3 months
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 8 Jun 2025.
- Individual participant dataSharing planned: No. To protect the privacy of the patients
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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.
Fuquan Zhang, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy in people with Cervical Neoplasm and Adaptive Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Acute toxicity (time frame: 3 months). 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 8 Jun 2025.