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Clinical Trial NCT05994300 for Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer 30 Adaptive Design

Active, not recruiting
Clinical Trial NCT05994300 is an interventional study for Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect that is active, not recruiting. It started on September 19, 2023 with plans to enroll 30 participants. Led by Peking Union Medical College Hospital, it is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on June 8, 2025.
Brief 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. 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 mode...Show More
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.
Official Title

Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer

Conditions
Cervical NeoplasmAdaptive RadiotherapyRadiotherapy; Adverse Effect
Other Study IDs
  • MHARTCC-Trial
NCT ID Number
NCT05994300
Start Date (Actual)
2023-09-19
Last Update Posted
2025-06-08
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
moderately hypofractionated radiotherapy
adaptive radiotherapy
cervical cancer.
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalModerately Hypofractionated Adaptive Radiotherapy
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
3 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Late toxicity
Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
3 years
Response evaluation evaluated with RECIST 1.1
Evaluated with RECIST 1.1
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.
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.
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.
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."
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.
3 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes

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

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

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1 Study Locations in 1 Countries

Beijing Municipality

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