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Clinical Trials in India / NCT05421650
Recruiting

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

NCT05421650 · tracked via the Priya Life Science India tracker
Sponsor
CHA University
Phase
N/A
Started
2022-08-01
Last updated
2025-04-09

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

CCRTSurgical debulking of lymph nodes + CCRT

CCRT: CCRT

Surgical debulking of lymph nodes + CCRT: Surgical debulking of lymph nodes + CCRT

Study 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

Sex
FEMALE
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
1\) Inclusion Criteria (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. 2\) Exclusion Criteria (1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Aster CMI Hospital Bengaluru India Not Yet Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Not Yet Recruiting
First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology Târgu Mureş Romania Not Yet Recruiting
Soon Chun Hyang University Hospital Cheonan Cheonan Chungcheongnam-do Recruiting
Korea University Ansan Hospital Ansan-si Gyeonggi-do Recruiting
Dongguk University Medical Center Goyang-si Gyeonggi-do Recruiting
National Cancer Center Goyang-si Gyeonggi-do Recruiting
CHA Bundang Medical Center, CHA University Seongnam-si Gyeonggi-do Recruiting
Pusan National University Yangsan Hospital Yangsan Gyeongsangbuk-do Recruiting
Samsung Changwon Medical Center Changwon Gyeongsangnam-do Recruiting
Chonnam National University Hwasun Hospital Hwasun Jeollanam-do Recruiting
Dongnam Institute of Radiological & Medical Sciences Busan South Korea Recruiting
Inje University Busan Paik Hospital Busan South Korea Recruiting
Kyungpook National University Chilgok Hospital Daegu South Korea Recruiting
Keimyung University Dongsan Hospital Daegu South Korea Recruiting
Gachon University Gil Medical Center Incheon South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Hanyang University Medical Center Seoul South Korea Recruiting
Konkuk University Medical Center Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Gangnam Severance Hospital Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Seoul ST. Mary's Hospital Seoul South Korea Recruiting
Ho Chi Minh City Oncology Hospital Ho Chi Minh City Vietnam Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05421650 on ClinicalTrials.gov ↗ ← All trials in India