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Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer | Clinical Trials | Clareo Health

RECRUITINGNA

Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer

NCT05378087•Chongqing University Cancer Hospital

View on ClinicalTrials.gov

Summary

The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.

Detailed Description

All eligible patients will be divided into the following two treatment groups nonrandomly. Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy). Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
•2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
•3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;
•4. ECOG score: 0 \~ 1;
•5. The expected survival \>6 months;
•6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.

Exclusion Criteria

•1. Activity or uncontrol severe infection;
•2. Liver cirrhosis or other decompensated liver disease;
•3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
•4. Chronic renal insufficiency or renal failure;
•5. Other malignancies were diagnosed within five years or needed treatments;
•6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
•7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
•8. A history of pelvic artery embolization;
•9. A history of pelvic radiotherapy;
•10. A history of partial hysterectomy or radical hysterectomy;
+4 more criteria

Locations (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

June 27, 2022

Primary Completion Date

April 30, 2027

Completion Date

December 31, 2032

Last Updated

August 31, 2023

Enrollment

1,956

ESTIMATED participants

Conditions

Locally Advanced Cervical Cancer

Interventions

Concurrent chemoradiation

RADIATION

Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation

PROCEDURE

Contacts

Dongling Zou, M.D.

CONTACT

13657690699 cqzl_zdl@163.com

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

NCT05975593

Locally Advanced Cervical CarcinomaLocally Advanced Cervical Cancer+8 more

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RECRUITINGPHASE2

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

NCT07104149

Female, Age ≥ 18 Years OldNo Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

Inclusion Criteria

Exclusion Criteria

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