RecruitingNot ApplicableNCT05421650

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

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

Sponsor

CHA University

Enrollment

240 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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: FEMALEMin Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether surgically removing enlarged lymph nodes (lymph node debulking) before standard chemoradiation improves outcomes in women with advanced cervical cancer that has spread to the lymph nodes (Stage IIICr). Normally, these patients receive radiation and chemotherapy without prior surgery on the lymph nodes. **You may be eligible if...** - You are a woman between 20 and 70 years old - You have been newly diagnosed with cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) - Your imaging shows enlarged lymph nodes in the pelvis or abdomen consistent with cancer spread - You have not received prior treatment for this cancer **You may NOT be eligible if...** - You have had prior radiation to the pelvis or prior cancer surgery - Your cancer has spread beyond the lymph nodes to distant organs - You are pregnant - You are unable to tolerate surgery - You have significant health conditions that increase surgical risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCCRT

CCRT

PROCEDURESurgical debulking of lymph nodes + CCRT

Surgical debulking of lymph nodes + CCRT

Locations(26)

Aster CMI Hospital

Bengaluru, India

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology

Târgu Mureş, Romania

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, South Korea

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangbuk-do, South Korea

Samsung Changwon Medical Center

Changwon, Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Dongnam Institute of Radiological & Medical Sciences

Busan, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Hanyang University Medical Center

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul ST. Mary's Hospital

Seoul, South Korea

Ho Chi Minh City Oncology Hospital

Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

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NCT05421650

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