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

Cervical Cancer Clinical Trial

Official title:

A Novel Predictive Model and Risk Stratification for Early Metastasis in Cervical Cancer Patients After Radiotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101966
• Other study ID #: prof.Sun
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: October 2023
• Source: Fujian Cancer Hospital
• Contact: Yang Sun, PhD
• Phone: +8615959028989
• Email: sunyang[@]fjzlhospital.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Cervical Cancer
• Neoplasm Metastasis
• Radiotherapy
• Risk Factor
• Uterine Cervical Neoplasms

Intervention

Radiation:
• external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)
Radical RT consisted of external pelvic beam radiotherapy (EBRT) and individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT).Cisplatin-based concurrent chemoradiotherapy (CCRT) was recommended for CC patients unless for economic status, age consideration and patients' desires.

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Li H, Wu X, Cheng X. Advances in diagnosis and treatment of metastatic cervical cancer. J Gynecol Oncol. 2016 Jul;27(4):e43. doi: 10.3802/jgo.2016.27.e43. — View Citation

Liu X, Meng Q, Wang W, Zhou Z, Zhang F, Hu K. Predictors of Distant Metastasis in Patients with Cervical Cancer Treated with Definitive Radiotherapy. J Cancer. 2019 Jul 5;10(17):3967-3974. doi: 10.7150/jca.31538. eCollection 2019. — View Citation

Okazawa-Sakai M, Mabuchi S, Isohashi F, Kawashima A, Yokoi E, Ogawa K, Kimura T. Predictors of distant relapse in patients with FIGO stage IIB-IVA cervical cancer treated with definitive radiotherapy. J Obstet Gynaecol Res. 2017 Nov;43(11):1743-1750. doi: — View Citation

Zeng W, Huang L, Lin H, Pan R, Liu H, Wen J, Liang Y, Yang H. Development and Validation of a Nomogram for Predicting Postoperative Distant Metastasis in Patients with Cervical Cancer. Med Sci Monit. 2022 Apr 12;28:e933379. doi: 10.12659/MSM.933379. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early distant metastases	Early distant metastasis defines as metastasis occurrence between 3 -12 months after radiotherapy.	3-12months