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

April 5, 2025 updated by: Ju-Won Roh, CHA University

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial).

  • Concurrent chemoradiation therapy (CCRT)
  • Surgical debulking of bulky or multiple lymph node followed by CCRT

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Bengaluru, India
        • Not yet recruiting
        • Aster CMI Hospital
        • Principal Investigator:
          • Somashekhar S P
  • Italy
      • Rome, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs
        • Principal Investigator:
          • Nicolò Bizzarri
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Principal Investigator:
          • Dae Hoon Jeong
      • Busan, Korea, Republic of, 46033
        • Recruiting
        • Dongnam Institute of Radiological & Medical Sciences
        • Principal Investigator:
          • Sang-Il Park
      • Daegu-si, Korea, Republic of, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Principal Investigator:
          • Chi Heum Cho
      • Daegu-si, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Dae Gy Hong
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Gwang-Beom LEE
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jae-Weon Kim
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Dae-Yeon KIM
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Gangnam Severance Hospital
        • Principal Investigator:
          • Jae Hoon KIM
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Chel Hun Choi
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary's Hospital
        • Principal Investigator:
          • Keun-Ho LEE
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Principal Investigator:
          • Sang Wun Kim
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Seong-Min Kim
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • Konkuk University Medical Center
        • Principal Investigator:
          • Seung-Hyuk Shim
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Medical Center
        • Principal Investigator:
          • Joong Sup Choi
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
        • Recruiting
        • Soon Chun Hyang University Hospital Cheonan
        • Principal Investigator:
          • Seob Jeon
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Principal Investigator:
          • Yung-Taek Ouh
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Principal Investigator:
          • Ji-Hyun Kim
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
        • Recruiting
        • Dongguk University Medical Center
        • Principal Investigator:
          • Chae Hyeong LEE
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Principal Investigator:
          • Hyun Park
    • Gyeongsangbuk-do
      • Yangsan, Gyeongsangbuk-do, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Principal Investigator:
          • Yogn Jung Song
    • Gyeongsangnam-do
      • Changwon, Gyeongsangnam-do, Korea, Republic of, 51353
        • Recruiting
        • Samsung Changwon Medical Center
        • Principal Investigator:
          • Min Kyu Kim
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Principal Investigator:
          • Seok Mo Kim
  • Romania
      • Targu Mures, Romania, 540136
        • Not yet recruiting
        • First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
        • Principal Investigator:
          • Mihai Capilna
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Active, not recruiting
        • Ho Chi Minh City Oncology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Concurrent chemoradiation therapy (CCRT)
Other: CCRT
CCRT
Experimental: Experimental group
Surgical debulking of bulky or multiple lymph node + CCRT
Procedure: Surgical debulking of lymph nodes + CCRT
Surgical debulking of lymph nodes + CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 3 years
Progression-free survival
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 years
Overall survival
3 years
Treatment-related complications
Time Frame: 3 years
Treatment-related complications
3 years
False positive rate & positive predictive value of bulky or multiple LN imaging
Time Frame: 6 months
To determine the accuracy of LN metastasis in imaging study
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Collaborators

Korean Gynecologic Oncology Group

Investigators

  • Principal Investigator: Ju-Won Roh, CHA University ilsan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG1047_DEBULK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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