Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
FEMALE
NCT05421650

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr

Led by CHA University · Updated on 2025-04-09

240

Participants Needed

26

Research Sites

439 weeks

Total Duration

On this page

Sponsors

C

CHA University

Lead Sponsor

K

Korean Gynecologic Oncology Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.

CONDITIONS

Official Title

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr

Who Can Participate

Age: 20Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

1) Inclusion Criteria

(1) Women aged ≥ 20 years and ≤ 70 years (2) Patients newly diagnosed with squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma (3) Patients with a short-axis diameter of the pelvic LN or para-aortic LN under the renal vein of ≥ 1.5 cm or ≥ 2 LNs with a short-axis diameter ≥ 1 cm in CT or MRI (PET-CT can be used as an auxiliary tool) (4) Patients with CCRT planned as a treatment for cervical cancer (5) Patients whose competency is Eastern Cooperative Oncology Group performance score 0-1 (6) Patients who have signed the approved informed consent form for study participants (7) Patients in whom surgical debulking for LN metastasis was possible, as confirmed by radiological examination.

2) Exclusion Criteria

(1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Aster CMI Hospital

Bengaluru, India

Not Yet Recruiting

2

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168

Not Yet Recruiting

3

First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology

Târgu Mureş, Romania, 540136

Not Yet Recruiting

4

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, South Korea, 31151

Actively Recruiting

5

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea, 15355

Actively Recruiting

6

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, South Korea, 10326

Actively Recruiting

7

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea, 10408

Actively Recruiting

8

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea, 13496

Actively Recruiting

9

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangbuk-do, South Korea, 50612

Actively Recruiting

10

Samsung Changwon Medical Center

Changwon, Gyeongsangnam-do, South Korea, 51353

Actively Recruiting

11

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea, 58128

Actively Recruiting

12

Dongnam Institute of Radiological & Medical Sciences

Busan, South Korea, 46033

Actively Recruiting

13

Inje University Busan Paik Hospital

Busan, South Korea, 47392

Actively Recruiting

14

Kyungpook National University Chilgok Hospital

Daegu, South Korea, 41404

Actively Recruiting

15

Keimyung University Dongsan Hospital

Daegu, South Korea, 42601

Actively Recruiting

16

Gachon University Gil Medical Center

Incheon, South Korea, 21565

Actively Recruiting

17

Korea University Anam Hospital

Seoul, South Korea, 02841

Actively Recruiting

18

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

19

Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

20

Hanyang University Medical Center

Seoul, South Korea, 04763

Actively Recruiting

21

Konkuk University Medical Center

Seoul, South Korea, 05030

Actively Recruiting

22

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

23

Gangnam Severance Hospital

Seoul, South Korea, 06273

Actively Recruiting

24

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

25

Seoul ST. Mary's Hospital

Seoul, South Korea, 06591

Actively Recruiting

26

Ho Chi Minh City Oncology Hospital

Ho Chi Minh City, Vietnam

Active, Not Recruiting

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Research Team

J

Ju-Won Roh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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