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

RecruitingNAAges 20 Years - 70 YearsFemaleCHA University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • CCRT
  • Surgical debulking of lymph nodes + CCRT
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Where

26 sites
Aster CMI Hospital
Bengaluru, India
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
Târgu Mureş, Romania
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Korea University Ansan Hospital
Ansan-si, South Korea
Dongguk University Medical Center
Goyang-si, South Korea
National Cancer Center
Goyang-si, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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