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

Last updated: April 5, 2025
Sponsor: CHA University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysfunctional Uterine Bleeding

Cervical Cancer

Vaginal Cancer

Treatment

CCRT

Surgical debulking of lymph nodes + CCRT

Clinical Study ID

NCT05421650
KGOG1047_DEBULK
  • Ages 20-70
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

  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.

  1. 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)

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: CCRT
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
December 31, 2030

Study Description

Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial).

  • Concurrent chemoradiation therapy (CCRT)

  • Surgical debulking of bulky or multiple lymph node followed by CCRT

Connect with a study center

  • Aster CMI Hospital

    Bengaluru,
    India

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168
    Italy

    Site Not Available

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan, Chungcheongnam-do 31151
    Korea, Republic of

    Active - Recruiting

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do 15355
    Korea, Republic of

    Active - Recruiting

  • Dongguk University Medical Center

    Goyang-si, Gyeonggi-do 10326
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam, Gyeonggi-do 13496
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangbuk-do 50612
    Korea, Republic of

    Active - Recruiting

  • Samsung Changwon Medical Center

    Changwon, Gyeongsangnam-do 51353
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do 58128
    Korea, Republic of

    Active - Recruiting

  • Dongnam Institute of Radiological & Medical Sciences

    Busan, 46033
    Korea, Republic of

    Active - Recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Hospital

    Daegu-si, 42601
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu-si, 41404
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Medical Center

    Seoul, 04763
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Seoul ST. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology

    Targu Mures, 540136
    Romania

    Site Not Available

  • Ho Chi Minh City Oncology Hospital

    Ho Chi Minh City,
    Vietnam

    Site Not Available

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