NCT06101966

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

October 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

October 21, 2023

Last Update Submit

October 21, 2023

Conditions

Cervical CancerRadiotherapyDistant MetastasisPrognostic ModelRisk Factor

Outcome Measures

Primary Outcomes (1)

  • Early distant metastases

    Early distant metastasis defines as metastasis occurrence between 3 -12 months after radiotherapy.

    3-12months

Study Arms (1)

cervical cancer patients with radiotherapy

The overall dose should be more than 75 Gy. patients received surgery should be excluded.

Radiation: external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)

Interventions

external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)RADIATION

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.

cervical cancer patients with radiotherapy

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cervical cancer patients recevied definitive radiotherapy.

You may qualify if:

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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Related Publications (4)

  • 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: 28816403RESULT

  • 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: 31417641RESULT

  • 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: 27171673RESULT

  • 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: 35410987RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Yang Sun, PhD

CONTACT

+8615959028989sunyang@fjzlhospital.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 26, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)