Surgical removal of lymph nodes in advanced cervical cancer before treatment

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial

This study is testing if removing large or multiple lymph nodes in women with advanced cervical cancer before starting chemotherapy and radiation can help them do better than just having the treatment alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 20 Years to 70 Years
• Sex: Female
• Sponsor: CHA University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 26 sites (Bengaluru and 25 other locations)
• Trial ID: NCT05421650 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include women aged 20 to 70 with newly diagnosed cervical cancer and significant lymph node metastasis.

Not a fit: Patients with other active cancers, those who are pregnant, or those for whom surgical debulking is not feasible will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes and survival rates for patients with advanced cervical cancer.

How similar studies have performed: While similar approaches have been explored, this specific method of surgical debulking prior to CCRT in cervical cancer is relatively novel.

Eligibility criteria

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 this trial is running

Bengaluru and 25 other locations

• Aster CMI Hospital — Bengaluru, India (Not_yet_recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Not_yet_recruiting)
• First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology — Târgu Mureş, Romania (Not_yet_recruiting)
• 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)
• Samsung Changwon Medical Center — Changwon, Gyeongsangnam-do, South Korea (Recruiting)
• Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea (Recruiting)
• Dongnam Institute of Radiological & Medical Sciences — Busan, South Korea (Recruiting)
• Inje University Busan Paik Hospital — Busan, South Korea (Recruiting)
• Kyungpook National University Chilgok Hospital — Daegu, South Korea (Recruiting)
• Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
• Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
• Korea University Anam Hospital — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Severance Hospital — Seoul, South Korea (Recruiting)
• Hanyang University Medical Center — Seoul, South Korea (Recruiting)
• Konkuk University Medical Center — Seoul, South Korea (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Seoul ST. Mary's Hospital — Seoul, South Korea (Recruiting)
• Ho Chi Minh City Oncology Hospital — Ho Chi Minh City, Vietnam (Active_not_recruiting)

Study contacts

• Principal investigator: Ju-Won Roh — CHA University Ilsan Medical Center
• Study coordinator: Ju-Won Roh

Conditions Cervical Cancer; Cervical cancer IIICr; Bulky or multiple lymph nodes; Surgical debulking of lymph nodes; Concurrent chemoradiation therapy