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

Observational Cervical Cancer Radiotherapy Prognostic Model MRI

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: Treatment mainly composed of 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, Prognostic Model, MRI. 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 Prognostic Model Based on MRI for Cervical Cancer Patients Treated With Radiotherapy

Overview

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.

Interventions

  • Radiation Treatment mainly composed of external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT) .
    The chemotherapy regimens included cisplatin (40 mg/m2) or nedaplatin (80 mg/m2) monotherapy or combined with paclitaxel (135 mg/m2) every three weeks during radiotherapy.

Primary outcome measures

  • overall survival [Time frame: 1-36 months]
Secondary outcome measures (1)
  • progression-free survival [Time frame: 1-36 months]

Eligibility criteria

Inclusion criteria

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

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

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

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
  • Cibula D, Potter R, Planchamp F, Avall-Lundqvist E, Fischerova D, Haie Meder C, Kohler C, Landoni F, Lax S, Lindegaard JC, Mahantshetty U, Mathevet P, McCluggage WG, McCormack M, Naik R, Nout R, Pignata S, Ponce J, Querleu D, Raspagliesi F, Rodolakis A, Tamussino K, Wimberger P, Raspollini MR. The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European S PMID 29728273
  • Matsuo K, Shimada M, Nakamura K, Takei Y, Ushijima K, Sumi T, Ohara T, Yahata H, Mikami M, Sugiyama T. Predictors for pathological parametrial invasion in clinical stage IIB cervical cancer. Eur J Surg Oncol. 2019 Aug;45(8):1417-1424. doi: 10.1016/j.ejso.2019.02.019. Epub 2019 Feb 18. PMID 30846298
  • Jiang W, He T, Liu S, Zheng Y, Xiang L, Pei X, Wang Z, Yang H. The PIK3CA E542K and E545K mutations promote glycolysis and proliferation via induction of the beta-catenin/SIRT3 signaling pathway in cervical cancer. J Hematol Oncol. 2018 Dec 14;11(1):139. doi: 10.1186/s13045-018-0674-5. PMID 30547809
  • Lindegaard JC, Petric P, Lindegaard AM, Tanderup K, Fokdal LU. Evaluation of a New Prognostic Tumor Score in Locally Advanced Cervical Cancer Integrating Clinical Examination and Magnetic Resonance Imaging. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):754-763. doi: 10.1016/j.ijrobp.2019.11.031. Epub 2019 Nov 30. PMID 31794837
  • Balcacer P, Shergill A, Litkouhi B. MRI of cervical cancer with a surgical perspective: staging, prognostic implications and pitfalls. Abdom Radiol (NY). 2019 Jul;44(7):2557-2571. doi: 10.1007/s00261-019-01984-7. PMID 30903231
  • Salib MY, Russell JHB, Stewart VR, Sudderuddin SA, Barwick TD, Rockall AG, Bharwani N. 2018 FIGO Staging Classification for Cervical Cancer: Added Benefits of Imaging. Radiographics. 2020 Oct;40(6):1807-1822. doi: 10.1148/rg.2020200013. Epub 2020 Sep 18. PMID 32946322
  • Tsuruoka S, Kataoka M, Hamamoto Y, Tokumasu A, Uwatsu K, Kanzaki H, Takata N, Ishikawa H, Ouchi A, Mochizuki T. Tumor growth patterns on magnetic resonance imaging and treatment outcomes in patients with locally advanced cervical cancer treated with definitive radiotherapy. Int J Clin Oncol. 2019 Sep;24(9):1119-1128. doi: 10.1007/s10147-019-01457-3. Epub 2019 May 11. PMID 31079257

Identifiers

NCT: NCT06197126 · SY-GO001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗