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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
India
Aster CMI Hospital
NOT_YET_RECRUITING
Bengaluru
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Rome
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Dongnam Institute of Radiological & Medical Sciences
RECRUITING
Busan
Inje University Busan Paik Hospital
RECRUITING
Busan
Samsung Changwon Medical Center
RECRUITING
Changwon
Soon Chun Hyang University Hospital Cheonan
RECRUITING
Cheonan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Dongguk University Medical Center
RECRUITING
Goyang-si
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Gangnam Severance Hospital
RECRUITING
Seoul
Hanyang University Medical Center
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Seoul ST. Mary's Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Romania
First Obstetrics and Gynecology Clinic, G. E. Palade University of Medicine, Pharmacy, Science and Technology
NOT_YET_RECRUITING
Târgu Mureş
Viet Nam
Ho Chi Minh City Oncology Hospital
ACTIVE_NOT_RECRUITING
Ho Chi Minh City
Contact Information
Primary
Ju-Won Roh
rohjuwon@hanmail.net
+82-31-782-8312
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 240
Treatments
Active_comparator: Control group
Concurrent chemoradiation therapy (CCRT)
Experimental: Experimental group
Surgical debulking of bulky or multiple lymph node + CCRT
Related Therapeutic Areas
Sponsors
Leads: CHA University
Collaborators: Korean Gynecologic Oncology Group

This content was sourced from clinicaltrials.gov