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Not yet recruiting NCT06101966

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

Observational Cervical Cancer Radiotherapy Distant Metastasis Prognostic Model

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT).
Who it may be relevant to
Registry conditions: Cervical Cancer, Radiotherapy, Distant Metastasis, Prognostic Model. Basic parameters: 20 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Early distant metastases [Time frame: 3-12months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fujian Cancer Hospital — Fuzhou

Publications

  • 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: 10.1111/jog.13446. Epub 2017 Aug 17. PMID 28816403
  • 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. PMID 31417641
  • 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. PMID 27171673
  • 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. PMID 35410987

Identifiers

NCT: NCT06101966 · prof.Sun

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗