Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer

June 4, 2025 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderately Hypofractionated Adaptive Radiotherapy
Radiation: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy

Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy

Drug: Concurrent Chemotherapy

Weekly cisplatin 40 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response evaluation evaluated with RECIST 1.1
Time Frame: One month after treatment
Evaluated with RECIST 1.1
One month after treatment
Late toxicity
Time Frame: 3 years
Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
3 years
Disease-free survival
Time Frame: 3 years
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.
3 years
Overall survival
Time Frame: 3 years
Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.
3 years
Quality of life (QoL)
Time Frame: 3 years
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."
3 years
Quality of life (QoL)
Time Frame: 3 years
QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality.
3 years
Assessment of tumor regression throughout EBRT
Time Frame: 3 months
To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Fuquan Zhang, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2023

Primary Completion (Actual)

July 22, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 5, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHARTCC-Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of the patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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