Health TrialsbyHealthPanel

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

ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-70
SponsorCHA University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • CCRT

    Other intervention

    CCRT

  • Surgical debulking of lymph nodes + CCRT

    Procedure/Surgery

    Surgical debulking of lymph nodes + CCRT

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival

Time frame
3 years

Secondary outcomes

1

OS

Overall survival

Time frame
3 years
2

Treatment-related complications

Treatment-related complications

Time frame
3 years
3

False positive rate & positive predictive value of bulky or multiple LN imaging

To determine the accuracy of LN metastasis in imaging study

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHA University

Lead sponsor

Korean Gynecologic Oncology Group

Collaborator

Source ClinicalTrials.gov
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