Surgical removal of lymph nodes in advanced cervical cancer before treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial, known as the DEBULK trial, is a prospective, multicenter, and randomized study aimed at evaluating the therapeutic effect of surgical debulking of bulky or multiple lymph nodes in patients with stage IIICr cervical cancer prior to concurrent chemoradiation therapy (CCRT). The study compares outcomes between patients undergoing surgical debulking followed by CCRT and those receiving CCRT alone. The goal is to determine if surgical intervention can improve prognosis and treatment efficacy in this patient population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Soon Chun Hyang University Hospital Cheonan
  Cheonan, Chungcheongnam-do, South Korea Recruiting
• Korea University Ansan Hospital
  Ansan-si, Gyeonggi-do, South Korea Recruiting
• Dongguk University Medical Center
  Goyang-si, Gyeonggi-do, South Korea Recruiting
• National Cancer Center
  Goyang-si, Gyeonggi-do, South Korea Recruiting
• CHA Bundang Medical Center, CHA University
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Pusan National University Yangsan Hospital
  Yangsan, Gyeongsangbuk-do, South Korea Recruiting

Study contacts

• Principal investigator: Ju-Won Roh — CHA University Ilsan Medical Center
• Study coordinator: Ju-Won Roh
• Email: rohjuwon@hanmail.net
• Phone: +82-31-782-8312

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.