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

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Procedure: Surgical debulking of bulky or multiple lymph nodes; Radiation: CCRT

• Registration Number: NCT05421650
• Lead Sponsor: CHA University

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

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Study Start: 2022-08-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2026-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	CCRT	Surgical debulking of bulky or multiple lymph node followed by CCRT
Control group	CCRT	Concurrent chemoradiation therapy (CCRT)
Experimental group	Surgical debulking of bulky or multiple lymph nodes	Surgical debulking of bulky or multiple lymph node followed by CCRT

Primary Outcome Measures

Name	Time	Method
PFS	3 years	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Treatment-related complications	3 years	Treatment-related complications
OS	3 years	Overall survival
False positive rate & positive predictive value of bulky or multiple LN imaging	6 months	To determine the accuracy of LN metastasis in imaging study

Trial Locations

Locations (14)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Daegu-si, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu-si, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangbuk-do, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Gyeonggi-do, Korea, Republic of

Dongguk University Medical Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of