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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 ID: NCT05421650
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
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Ju-Won Roh
Affiliation: CHA University Ilsan Medical Center
Role: PRINCIPAL_INVESTIGATOR