NCT05421650

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: CHA University · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
OTHER	CCRT	CCRT
PROCEDURE	Surgical debulking of lymph nodes + CCRT	Surgical debulking of lymph nodes + CCRT

Timeline

• Start date: 2022-08-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2022-06-16
• Last updated: 2025-04-09

Locations

26 sites across 5 countries: India, Italy, Romania, South Korea, Vietnam