A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy

Not yet recruiting

• Conditions: Risk Factor; Distant Metastasis; Cervical Cancer; Radiotherapy; Prognostic Model
• Interventions: Radiation: external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)

• Registration Number: NCT06101966
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

This study aims to help to screen out appropriate cases for consolidation therapy and more intensive follow up.

Detailed Description

Some cervical cancer patients experienced distant metastasis quickly after receiving complete radiotherapy and have a worse prognosis. However, there were few studies focused on these patients and with early distant metastasis. It is significant to predictive and screen out cervial cancer patients with a high risk of early metastasis for more comprehensive treatments and follow-up plans

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-21
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Study Start: 2023-12-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• patients confirmed as cervical cancer by biopsies and treated with radiotherapy were initially enrolled

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Exclusion Criteria

• (1) patients treated with surgery. (2) patient received incomplete treatment somewhere else. (3) patients with cancer history. (4) patients with pelvic surgery history. (5) patients without complete pre-treatment medical information. (6) patients with unfinished radical radiotherapy. (7) patients suffered from metastasis within 3 months after radiotherapy. (8) patients without complete 1-year follow-up materials

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cervical cancer patients with radiotherapy	external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)	The overall dose should be more than 75 Gy. patients received surgery should be excluded.

Primary Outcome Measures

Name	Time	Method
Early distant metastases	3-12months	Early distant metastasis defines as metastasis occurrence between 3 -12 months after radiotherapy.

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China