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
- Diseases
- Cervical cancer
- 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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aster CMI Hospital Coordinator of this site? Confirm its status | Bengaluru | India | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Recruiting |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Dongnam Institute of Radiological & Medical Sciences Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Samsung Changwon Medical Center Coordinator of this site? Confirm its status | Changwon | South Korea | Recruiting |
| Soon Chun Hyang University Hospital Cheonan Coordinator of this site? Confirm its status | Cheonan | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Dongguk University Medical Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| CHA Bundang Medical Center, CHA University Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Hanyang University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Recruiting |
| First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Not yet recruiting |
| Ho Chi Minh City Oncology Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.