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NCT05421650Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
13 Jun 2022
Start date
1 Aug 2022
Primary completion date
31 Dec 2030
Lead sponsor
CHA University
NCT number
NCT05421650

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 1 Aug 2022 to the primary completion date, 31 Dec 2030
  • 26 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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)

Age in the registry: 20 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aster CMI Hospital
Coordinator of this site? Confirm its status
BengaluruIndiaNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyNot yet recruiting
Korea University Ansan Hospital
Coordinator of this site? Confirm its status
Ansan-siSouth KoreaRecruiting
Inje University Busan Paik Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaRecruiting
Dongnam Institute of Radiological & Medical Sciences
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BusanSouth KoreaRecruiting
Samsung Changwon Medical Center
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ChangwonSouth KoreaRecruiting
Soon Chun Hyang University Hospital Cheonan
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CheonanSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaRecruiting
National Cancer Center
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Goyang-siSouth KoreaRecruiting
Dongguk University Medical Center
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
CHA Bundang Medical Center, CHA University
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Seongnam-siSouth KoreaRecruiting
Seoul St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Hanyang University Medical Center
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SeoulSouth KoreaRecruiting
Gangnam Severance Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Severance hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Konkuk University Medical Center
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SeoulSouth KoreaRecruiting
Pusan National University Yangsan Hospital
Coordinator of this site? Confirm its status
YangsanSouth KoreaRecruiting
First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
Coordinator of this site? Confirm its status
Târgu MureşRomaniaNot yet recruiting
Ho Chi Minh City Oncology Hospital
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.