MRI-based Signatures for Survival Prediction in Cervical Cancer With Radiotherapy

Not yet recruiting

• Conditions: MRI; Radiotherapy; Prognostic Model; Cervical Cancer
• Interventions: Radiation: Treatment mainly composed of external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT) .

• Registration Number: NCT06197126
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

This study aims to validate the value of tumor involvement features based on MRI in cervical cancer, facilitate the development of a more appropriate model for risk stratification, and help patients with varying risk profiles make appropriate decisions in treatment selection and follow-up plans.

Detailed Description

Even with the development of advanced technology, the prognosis for CC patients who received radiotherapy is still an intractable problem. Almost 40% suffered disease recurrence among locally advanced patients after radiotherapy and the reported 5-year overall survival is 50-70%. The present FIGO staging is controversial in pre-treatment assessment, which is mainly based on physical examination. An ambiguous diagnosis leads to different treatment strategies and follow-up plans, which is associated with prognosis non-improvement. Incorporation of the tumor involvement features based on the MRI into pre-treatment assessment could standardize and improve the consistency and repeatability of diagnosis.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study Start: 2024-01-01
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• (1) pathologically confirmed CC, (2) initially treated in our center

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Exclusion Criteria

• (1) lack of pre-treatment MRI, (2) prior anti-tumor treatment, (3) pelvic surgery history, (4) incomplete therapy, (5) loss of follow-up

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cervical cancer patients with radiotherapy	Treatment mainly composed of external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT) .	Radiotherapy is the main treatment strategy with an overall dose of over 75Gy.

Primary Outcome Measures

Name	Time	Method
overall survival	1-36 months	the interval from diagnostic day to death or the last follow-up

Secondary Outcome Measures

Name	Time	Method
progression-free survival	1-36 months	the interval from diagnostic day to death, the last follow-up, or the onset of regional recurrence or distant metastasis

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China