Status:
RECRUITING
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
Lead Sponsor:
CHA University
Collaborating Sponsors:
Korean Gynecologic Oncology Group
Conditions:
Cervical Cancer
Eligibility:
FEMALE
20-70 years
Phase:
NA
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 chemo...
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 ...
Eligibility Criteria
Inclusion
- 1\) Inclusion Criteria
- (1) Women aged ≥ 20 years and ≤ 70 years (2) Patients newly diagnosed with squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma (3) Patients with a short-axis diameter of the pelvic LN or para-aortic LN under the renal vein of ≥ 1.5 cm or ≥ 2 LNs with a short-axis diameter ≥ 1 cm in CT or MRI (PET-CT can be used as an auxiliary tool) (4) Patients with CCRT planned as a treatment for cervical cancer (5) Patients whose competency is Eastern Cooperative Oncology Group performance score 0-1 (6) Patients who have signed the approved informed consent form for study participants (7) Patients in whom surgical debulking for LN metastasis was possible, as confirmed by radiological examination.
- 2\) Exclusion Criteria
- (1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05421650
Start Date
August 1 2022
End Date
December 31 2030
Last Update
April 9 2025
Active Locations (26)
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1
Aster CMI Hospital
Bengaluru, India
2
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
3
First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
Târgu Mureş, Romania, 540136
4
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, South Korea, 31151