Actively Recruiting
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
Eligibility Criteria
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)
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
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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
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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