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

February 7, 2023 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 (Anticipated)

234

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 Locations

  • Korea, Republic of
      • 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
      • 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-Youn 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, 04763
        • Not yet recruiting
        • Hanyang University Medical Center
        • Principal Investigator:
          • Joong Sup Choi
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Principal Investigator:
          • Ha Kyun Chang
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Principal Investigator:
          • Myung-Chul Lim
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
        • Not yet recruiting
        • Dongguk University Medical Center
        • Principal Investigator:
          • Chae Hyeong LEE
    • Gyeongsangbuk-do
      • Yangsan, Gyeongsangbuk-do, Korea, Republic of, 50612
        • Not yet recruiting
        • Pusan National University Yangsan Hospital
        • Principal Investigator:
          • Yogn Jung Song

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

Genders Eligible for Study

Female

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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.
EXPERIMENTAL: Experimental group
Surgical debulking of bulky or multiple lymph node followed by 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.
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.
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.

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

National Cancer Center, Korea
Samsung Medical Center
Seoul St. Mary's Hospital
Asan Medical Center
Seoul National University Hospital
Gachon University Gil Medical Center
Hanyang University
Kyungpook National University Chilgok Hospital
Ewha Womans University
Gangnam Severance Hospital
Severance Hospital
Keimyung University Dongsan Medical Center
Pusan National University Yangsan Hospital
Korean Gynecologic Oncology Group
DongGuk University
Korea University Ansan Hospital

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

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 (ANTICIPATED)

March 31, 2026

Study Completion (ANTICIPATED)

March 31, 2029

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 (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

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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