Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Surgical debulking of bulky or multiple lymph node followed by CCRT

1. Radiation: Extended field-external beam radiation therapy (EF-EBRT) + brachytherapy + lymph node boost.
2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
3. Radiation and chemotherapy are administered concurrently.

CCRT

1. Open/minimally invasive method.
2. Surgical debulking of bulky or multiple lymph nodes.
3. Postoperative imaging evaluation to determine whether the lymph node has been successfully removed.

Surgical debulking of bulky or multiple lymph nodes

1. Radiation: EBRT/EF-EBRT + brachytherapy + lymph node boost.
2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
3. Radiation and chemotherapy are administered concurrently.

Ju-Won Roh

Ha Kyun Chang

Chae Hyeong LEE

Myung-Chul Lim

Yogn Jung Song

Dae Gy Hong

Chi Heum Cho

Gwang-Beom LEE

Jae-Weon Kim

Sang Wun Kim

Joong Sup Choi

Dae-Youn KIM

Jae Hoon KIM

Chel Hun Choi

Keun-Ho LEE

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.

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

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

To determine the accuracy of LN metastasis in imaging study

Gachon University Gil Medical Center

Seoul St. Mary's Hospital

Korea University Ansan Hospital

National Cancer Center, Korea

Samsung Medical Center

Gangnam Severance Hospital

Asan Medical Center

Ewha Womans University

Hanyang University

DongGuk University

Seoul National University Hospital

Severance Hospital

Keimyung University Dongsan Medical Center

Kyungpook National University Chilgok Hospital

Pusan National University Yangsan Hospital

Korean Gynecologic Oncology Group

CHA University

Study Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr	NCT05421650	Cervical Cancer	CCRT Surgical debulk... CCRT	20 Years - 70 Years	CHA University
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr	NCT05421650	Cervical Cancer	CCRT Surgical debulk... CCRT	20 Years - 70 Years	CHA University

Spots Global Cancer Trial Database for surgical debulking of bulky or multiple lymph nodes