Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer

Not Applicable

Active, not recruiting

• Conditions: Radiotherapy; Adverse Effect; Cervical Neoplasm; Adaptive Radiotherapy
• Interventions: Radiation: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy

• Registration Number: NCT05994300
• Lead Sponsor: Peking Union Medical College Hospital

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 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 Timeline

• Study First Submitted: 2023-08-05
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-16
• Study Start: 2023-09-19
• Status Verified: 2024-05
• Primary Completion: 2024-09-18
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderately Hypofractionated Adaptive Radiotherapy	Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy	-

Primary Outcome Measures

Name	Time	Method
Acute toxicity	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.

Secondary Outcome Measures

Name	Time	Method
Late toxicity	3 years	Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Response evaluation evaluated with RECIST 1.1	One month after treatment	Evaluated with RECIST 1.1
Disease-free survival	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.
Overall survival	3 years	Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.
Quality of life (QoL)	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."

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China