The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05421650
Recruitment Status : Recruiting
First Posted : June 16, 2022
Last Update Posted : February 9, 2023
Sponsor:
Collaborators:
Gachon University Gil Medical Center
Seoul St. Mary's Hospital
Korea University Ansan Hospital
National Cancer Center, Korea
Samsung Medical Center
Gangnam Severance Hospital
Asan Medical Center
Ewha Womans University
Hanyang University
DongGuk University
Seoul National University Hospital
Severance Hospital
Keimyung University Dongsan Medical Center
Kyungpook National University Chilgok Hospital
Pusan National University Yangsan Hospital
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Ju-Won Roh, CHA University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: CCRT Procedure: Surgical debulking of bulky or multiple lymph nodes Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : March 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Control group
Concurrent chemoradiation therapy (CCRT)
 Radiation: CCRT
  1. Radiation: Extended field-external beam radiation therapy (EF-EBRT) + brachytherapy + lymph node boost.
  2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
  3. Radiation and chemotherapy are administered concurrently.
Experimental: Experimental group
Surgical debulking of bulky or multiple lymph node followed by CCRT
 Procedure: Surgical debulking of bulky or multiple lymph nodes
  1. Open/minimally invasive method.
  2. Surgical debulking of bulky or multiple lymph nodes.
  3. Postoperative imaging evaluation to determine whether the lymph node has been successfully removed.

Radiation: CCRT
  1. Radiation: EBRT/EF-EBRT + brachytherapy + lymph node boost.
  2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
  3. Radiation and chemotherapy are administered concurrently.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PFS [ Time Frame: 3 years ]
    Progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 3 years ]
    Overall survival

  2. Treatment-related complications [ Time Frame: 3 years ]
    Treatment-related complications

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

1) Inclusion Criteria

  1. Women ≥20 years and ≤ 70 years of age
  2. Cervical histopathology results of newly diagnosed squamous cell carcinoma, glandular epithelial cell, or adenosquamous carcinoma
  3. When the radiology examinations such as CT, MRI, or PET-CT show the short-axis of the pelvic lymph node or paraaortic lymph node under the renal vein is ≥ 2cm, or more than 3 lymph nodes with a short axis ≥ 1 cm
  4. When concurrent chemoradiation therapy is planned as a treatment for cervical cancer
  5. Patient whose competency is ECOG performance score 0-1
  6. A patient which has signed the approved informed consent form for study subjects
  7. A patient for which it is determined that pre-surgical debulking is possible for lymph node metastasis as confirmed by radiological examination

2) Exclusion Criteria

  1. A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years
  2. A patient that is pregnant or plans to become pregnant during the clinical study period
  3. A patient with any active infectious disease or incurable severe inflammation.
  4. When surgery is not possible due to internal or surgical disease
  5. When chemotherapy is impossible due to internal or surgical disease
  6. Patient with a history of pelvic radiation therapy
  7. Patient with a history of subtotal hysterectomy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05421650


Contacts
Layout table for location contacts
Contact: Ju-Won Roh +82-31-782-8312 rohjuwon@hanmail.net

Locations
Layout table for location information
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
Principal Investigator: Ha Kyun Chang         
Dongguk University Medical Center Not yet recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
Principal Investigator: Chae Hyeong LEE         
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Principal Investigator: Myung-Chul Lim         
Pusan National University Yangsan Hospital Not yet recruiting
Yangsan, Gyeongsangbuk-do, Korea, Republic of, 50612
Principal Investigator: Yogn Jung Song         
Kyungpook National University Chilgok Hospital Recruiting
Daegu-si, Korea, Republic of, 41404
Principal Investigator: Dae Gy Hong         
Keimyung University Dongsan Hospital Recruiting
Daegu-si, Korea, Republic of, 42601
Principal Investigator: Chi Heum Cho         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Principal Investigator: Gwang-Beom LEE         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Principal Investigator: Jae-Weon Kim         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Principal Investigator: Sang Wun Kim         
Hanyang University Medical Center Not yet recruiting
Seoul, Korea, Republic of, 04763
Principal Investigator: Joong Sup Choi         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Principal Investigator: Dae-Youn KIM         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Principal Investigator: Jae Hoon KIM         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Principal Investigator: Chel Hun Choi         
Seoul ST. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Principal Investigator: Keun-Ho LEE         
Sponsors and Collaborators
CHA University
Gachon University Gil Medical Center
Seoul St. Mary's Hospital
Korea University Ansan Hospital
National Cancer Center, Korea
Samsung Medical Center
Gangnam Severance Hospital
Asan Medical Center
Ewha Womans University
Hanyang University
DongGuk University
Seoul National University Hospital
Severance Hospital
Keimyung University Dongsan Medical Center
Kyungpook National University Chilgok Hospital
Pusan National University Yangsan Hospital
Korean Gynecologic Oncology Group
Investigators
Layout table for investigator information
Principal Investigator: Ju-Won Roh CHA University Ilsan Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Ju-Won Roh, Study Principal Investigator, CHA University
ClinicalTrials.gov Identifier: NCT05421650    
Other Study ID Numbers: KGOG1047_DEBULK
First Posted: June 16, 2022    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ju-Won Roh, CHA University:
Cervical cancer IIICr
Bulky or multiple lymph nodes
Surgical debulking of lymph nodes
Concurrent chemoradiation therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases