Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
- Conditions
- Cervical Cancer
- Interventions
- Procedure: Surgical debulking of bulky or multiple lymph nodesRadiation: CCRT
- Registration Number
- NCT05421650
- Lead Sponsor
- CHA University
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group CCRT Surgical debulking of bulky or multiple lymph node followed by CCRT Control group CCRT Concurrent chemoradiation therapy (CCRT) Experimental group Surgical debulking of bulky or multiple lymph nodes Surgical debulking of bulky or multiple lymph node followed by CCRT
- Primary Outcome Measures
Name Time Method PFS 3 years Progression-free survival
- Secondary Outcome Measures
Name Time Method Treatment-related complications 3 years Treatment-related complications
OS 3 years Overall survival
False positive rate & positive predictive value of bulky or multiple LN imaging 6 months To determine the accuracy of LN metastasis in imaging study
Trial Locations
- Locations (26)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Dongnam Institute of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Samsung Changwon Medical Center
🇰🇷Changwon, Gyeongsangnam-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam-do, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Ho Chi Minh City Oncology Hospital
🇻🇳Ho Chi Minh City, Vietnam
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
🇷🇴Targu Mures, Romania
Korea University Ansan Hospital
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Dongguk University Medical Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangbuk-do, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu-si, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu-si, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Aster CMI Hospital
🇮🇳Bengaluru, India