Back to resultsTherapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CCRT
Surgical debulking of bulky or multiple lymph nodes
CCRT
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer IIICr, Bulky or multiple lymph nodes, Surgical debulking of lymph nodes, Concurrent chemoradiation therapy
Eligibility Criteria
Inclusion Criteria:
- The women with aged 20-70
- Newly diagnosed cervix cancer with pathology of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma
Cervix cancer IIICr with pelvic lymph nodes (LN) or paraaortic LN below the renal vein in imaging study of CT, MRI or PET-CT
- short axis diameter of LN ≥ 2cm or
- the number of LN ≥ 3
- The concurrent chemoradiation therapy planned for cervical cancer treatment
- Performance scale 0-1 with ECOG score
- The patients who signed an approved subject consent form
- The patients whose debulking surgery of lymph node confirmed by imaging study is possible
Exclusion Criteria:
- The patients who are diagnosed with cancer of other organs (excluding stage 0 cancer or thyroid cancer) within 5 years
- The patients who are pregnant or plan to become pregnant during the clinical trial
- The patients with severe inflammation that is active or incurable
- The patients whose surgery is not possible due to medical or surgical complications
- The patients whose chemotherapy is not possible due to medical or surgical complications
- The patients with a history of pelvic radiation therapy
- The patients who underwent subtotal hysterectomy
Sites / Locations
- Korea University Ansan HospitalRecruiting
- Dongguk University Medical Center
- National Cancer CenterRecruiting
- Pusan National University Yangsan Hospital
- Kyungpook National University Chilgok HospitalRecruiting
- Keimyung University Dongsan HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Severance HospitalRecruiting
- Hanyang University Medical Center
- Asan Medical CenterRecruiting
- Gangnam Severance HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul ST. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Concurrent chemoradiation therapy (CCRT)
Surgical debulking of bulky or multiple lymph node followed by CCRT
Outcomes
Primary Outcome Measures
PFS
Progression-free survival
Secondary Outcome Measures
OS
Overall survival
Treatment-related complications
Treatment-related complications
False positive rate & positive predictive value of bulky or multiple LN imaging
To determine the accuracy of LN metastasis in imaging study
Full Information
NCT ID
NCT05421650
First Posted
June 13, 2022
Last Updated
February 7, 2023
Sponsor
CHA University
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
1. Study Identification
Unique Protocol Identification Number
NCT05421650
Brief Title
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
Official Title
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer IIICr, Bulky or multiple lymph nodes, Surgical debulking of lymph nodes, Concurrent chemoradiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Concurrent chemoradiation therapy (CCRT)
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Surgical debulking of bulky or multiple lymph node followed by CCRT
Intervention Type
Radiation
Intervention Name(s)
CCRT
Intervention Description
Radiation: Extended field-external beam radiation therapy (EF-EBRT) + brachytherapy + lymph node boost.
Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
Radiation and chemotherapy are administered concurrently.
Intervention Type
Procedure
Intervention Name(s)
Surgical debulking of bulky or multiple lymph nodes
Intervention Description
Open/minimally invasive method.
Surgical debulking of bulky or multiple lymph nodes.
Postoperative imaging evaluation to determine whether the lymph node has been successfully removed.
Intervention Type
Radiation
Intervention Name(s)
CCRT
Intervention Description
Radiation: EBRT/EF-EBRT + brachytherapy + lymph node boost.
Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
Radiation and chemotherapy are administered concurrently.
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
3 years
Title
Treatment-related complications
Description
Treatment-related complications
Time Frame
3 years
Title
False positive rate & positive predictive value of bulky or multiple LN imaging
Description
To determine the accuracy of LN metastasis in imaging study
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1) Inclusion Criteria
Women ≥20 years and ≤ 70 years of age
Cervical histopathology results of newly diagnosed squamous cell carcinoma, glandular epithelial cell, or adenosquamous carcinoma
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
When concurrent chemoradiation therapy is planned as a treatment for cervical cancer
Patient whose competency is ECOG performance score 0-1
A patient which has signed the approved informed consent form for study subjects
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
A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years
A patient that is pregnant or plans to become pregnant during the clinical study period
A patient with any active infectious disease or incurable severe inflammation.
When surgery is not possible due to internal or surgical disease
When chemotherapy is impossible due to internal or surgical disease
Patient with a history of pelvic radiation therapy
Patient with a history of subtotal hysterectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ju-Won Roh
Phone
+82-31-782-8312
Email
rohjuwon@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju-Won Roh
Organizational Affiliation
CHA University Ilsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ha Kyun Chang
Facility Name
Dongguk University Medical Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10326
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chae Hyeong LEE
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Chul Lim
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangbuk-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yogn Jung Song
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu-si
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Gy Hong
Facility Name
Keimyung University Dongsan Hospital
City
Daegu-si
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Heum Cho
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwang-Beom LEE
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Weon Kim
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Wun Kim
Facility Name
Hanyang University Medical Center
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joong Sup Choi
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae-Youn KIM
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hoon KIM
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chel Hun Choi
Facility Name
Seoul ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun-Ho LEE
12. IPD Sharing Statement
Plan to Share IPD
No
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Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
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