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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

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

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

Other trials in China

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.

Conditions: Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect
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 groups in NCT05994300
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.

19 Sep 202331 Dec 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Radiotherapy for Gynecologic Cancer With Up to 10 Active Metastatic Lesions
Cervical Cancer, Gynecologic Cancer
Not yet recruitingPhase 2
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
Cervical Intraepithelial Neoplasia Grade 3
Active, not recruitingPhase 2
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 3
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma

All Cervical Neoplasm trials