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Cervical CancerNCT05421650

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

A study testing CCRT and Surgical debulking of lymph nodes + CCRT in people with Cervical Cancer, run by CHA University at 26 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
CCRT and Surgical debulking of lymph nodes + CCRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
26 sitesin 5 countries
Study dates
1 Aug 2022to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  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)

Trial locations and contacts

26 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Ju-Won Roh contact

+82-31-782-8312

rohjuwon@hanmail.net

26 sites in 5 countries

South Korea22 sites, 22 recruiting

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

    Yung-Taek Ouh

    Recruiting

  • Dongnam Institute of Radiological & Medical Sciences

    Busan, 46033

    Sang-Il Park

    Recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392

    Dae Hoon Jeong

    Recruiting

  • Samsung Changwon Medical Center

    Changwon, Gyeongsangnam-do, 51353

    Min Kyu Kim

    Recruiting

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan, Chungcheongnam-do, 31151

    Seob Jeon

    Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Dae Gy Hong

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601

    Chi Heum Cho

    Recruiting

  • Dongguk University Medical Center

    Goyang-si, Gyeonggi-do, 10326

    Chae Hyeong LEE

    Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Ji-Hyun Kim

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

    Seok Mo Kim

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Gwang-Beom LEE

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

    Hyun Park

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Seong-Min Kim

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Jae-Weon Kim

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Sang Wun Kim

    Recruiting

  • Hanyang University Medical Center

    Seoul, 04763

    Joong Sup Choi

    Recruiting

  • Konkuk University Medical Center

    Seoul, 05030

    Seung-Hyuk Shim

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Dae-Yeon KIM

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Jae Hoon KIM

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Chel Hun Choi

    Recruiting

  • Seoul ST. Mary's Hospital

    Seoul, 06591

    Keun-Ho LEE

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangbuk-do, 50612

    Yogn Jung Song

    Recruiting

Other trials in South Korea

India1 site, 1 recruiting

  • Aster CMI Hospital

    Bengaluru

    Somashekhar S P

    Not yet recruiting

Other trials in India

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

    Nicolò Bizzarri

    Not yet recruiting

Other trials in Italy

Romania1 site, 1 recruiting

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

    Târgu Mureş, 540136

    Mihai Capilna

    Not yet recruiting

Other trials in Romania

Vietnam1 site

  • Ho Chi Minh City Oncology Hospital

    Ho Chi Minh City

    Active, not recruiting

Other trials in Vietnam

About this study

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

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.

Read the detailed 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
Conditions
Cervical Cancer
Being tested
CCRT, Surgical debulking of lymph nodes + CCRT
Keywords
Cervical cancer IIICr, Bulky or multiple lymph nodes, Surgical debulking of lymph nodes, Concurrent chemoradiation therapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCRTOther

    CCRT

  • Surgical debulking of lymph nodes + CCRTProcedure or surgery

    Surgical debulking of lymph nodes + CCRT

Study groups in NCT05421650
Study groupRoleWhat they receive
Control groupActive comparatorConcurrent chemoradiation therapy (CCRT)
Receives: Other: CCRT
Experimental groupExperimentalSurgical debulking of bulky or multiple lymph node + CCRT
Receives: Procedure: Surgical debulking of lymph nodes + CCRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-free survival

    Measured: 3 years

Secondary outcomes (3)

  1. OS

    Overall survival

    Measured: 3 years

  2. Treatment-related complications

    Treatment-related complications

    Measured: 3 years

  3. False positive rate & positive predictive value of bulky or multiple LN imaging

    To determine the accuracy of LN metastasis in imaging study

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05421650
Sponsor's protocol ID
KGOG1047_DEBULK
Status last verified
Apr 2025
First submitted
13 Jun 2022
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Jung KW, Won YJ, Kong HJ, Lee ES. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2016. Cancer Res Treat. 2019 Apr;51(2):417-430. doi: 10.4143/crt.2019.138. Epub 2019 Mar 18.

    PubMed 30913865

  • Bhatla N, Berek JS, Cuello Fredes M, Denny LA, Grenman S, Karunaratne K, Kehoe ST, Konishi I, Olawaiye AB, Prat J, Sankaranarayanan R, Brierley J, Mutch D, Querleu D, Cibula D, Quinn M, Botha H, Sigurd L, Rice L, Ryu HS, Ngan H, Maenpaa J, Andrijono A, Purwoto G, Maheshwari A, Bafna UD, Plante M, Natarajan J. Revised FIGO staging for carcinoma of the cervix uteri. Int J Gynaecol Obstet. 2019 Apr;145(1):129-135. doi: 10.1002/ijgo.12749. Epub 2019 Jan 17.

    PubMed 30656645

  • Suprasert P, Srisomboon J, Charoenkwan K, Siriaungul S, Khunamornpong S, Siriaree S, Phongnarisorn C, Lorvidhaya V. Outcomes of abandoned radical hysterectomy in patients with stages IB-IIA cervical cancer found to have positive nodes during the operation. Int J Gynecol Cancer. 2005 May-Jun;15(3):498-502. doi: 10.1111/j.1525-1438.2005.15315.x.

    PubMed 15882176

  • Abu-Rustum NR, Yashar CM, Bean S, Bradley K, Campos SM, Chon HS, Chu C, Cohn D, Crispens MA, Damast S, Fisher CM, Frederick P, Gaffney DK, Giuntoli R, Han E, Huh WK, Lurain Iii JR, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Sisodia R, Tillmanns T, Ueda S, Urban R, Wyse E, McMillian NR, Motter AD. NCCN Guidelines Insights: Cervical Cancer, Version 1.2020. J Natl Compr Canc Netw. 2020 Jun;18(6):660-666. doi: 10.6004/jnccn.2020.0027.

    PubMed 32502976

  • Song S, Kim JY, Kim YJ, Yoo HJ, Kim SH, Kim SK, Lim MC, Kang S, Seo SS, Park SY. The size of the metastatic lymph node is an independent prognostic factor for the patients with cervical cancer treated by definitive radiotherapy. Radiother Oncol. 2013 Jul;108(1):168-73. doi: 10.1016/j.radonc.2013.04.015. Epub 2013 May 14.

    PubMed 23684584

  • Oh J, Seol KH, Choi YS, Lee JW, Bae JY. Clinical significance of lymph node size in locally advanced cervical cancer treated with concurrent chemoradiotherapy. Yeungnam Univ J Med. 2019 May;36(2):115-123. doi: 10.12701/yujm.2019.00143. Epub 2019 Feb 21.

    PubMed 31620623

  • Pedone Anchora L, Carbone V, Gallotta V, Fanfani F, Cosentino F, Turco LC, Fedele C, Bizzarri N, Scambia G, Ferrandina G. Should the Number of Metastatic Pelvic Lymph Nodes be Integrated into the 2018 Figo Staging Classification of Early Stage Cervical Cancer? Cancers (Basel). 2020 Jun 12;12(6):1552. doi: 10.3390/cancers12061552.

    PubMed 32545508

  • Zhou J, Wu SG, Sun JY, Liao XL, Li FY, Lin HX, Yang LC, He ZY. Incorporation of the number of positive lymph nodes leads to better prognostic discrimination of node-positive early stage cervical cancer. Oncotarget. 2017 Apr 18;8(16):26057-26065. doi: 10.18632/oncotarget.15220.

    PubMed 28199962

  • Wang SC, Lin LC, Kuo YT, Lin YW. Radiographic Number of Positive Pelvic Lymph Nodes as a Prognostic Factor in Cervical Cancer Treated With Definitive Concurrent Chemoradiotherapy or Intensity-Modulated Radiotherapy. Front Oncol. 2018 Nov 30;8:546. doi: 10.3389/fonc.2018.00546. eCollection 2018.

    PubMed 30555798

  • Tohyama A, Murakami M, Yoshino K. Strategies for the Treatment of Cervical Cancer with Bulky Pelvic Lymph Nodes: An Overview of the Current Evidence. J UOEH. 2020;42(4):317-325. doi: 10.7888/juoeh.42.317.

    PubMed 33268608

  • Marnitz S, Kohler C, Roth C, Fuller J, Hinkelbein W, Schneider A. Is there a benefit of pretreatment laparoscopic transperitoneal surgical staging in patients with advanced cervical cancer? Gynecol Oncol. 2005 Dec;99(3):536-44. doi: 10.1016/j.ygyno.2005.07.005. Epub 2005 Aug 29.

    PubMed 16126259

  • Yang J, Delara R, Magrina J, Magtibay P, Yi J, Langstraat C, Robertson M, Dinh T, Butler K. Comparing survival outcomes between surgical and radiographic lymph node assessment in locally advanced cervical cancer: A propensity score-matched analysis. Gynecol Oncol. 2020 Feb;156(2):320-327. doi: 10.1016/j.ygyno.2019.12.009. Epub 2019 Dec 14.

    PubMed 31843274

  • Lee M, Choi CH, Chun YK, Kim YH, Lee KB, Lee SW, Shim SH, Song YJ, Roh JW, Chang SJ, Lee JM. Surgical manual of the Korean Gynecologic Oncology Group: classification of hysterectomy and lymphadenectomy. J Gynecol Oncol. 2017 Jan;28(1):e5. doi: 10.3802/jgo.2017.28.e5. Epub 2016 Aug 19.

    PubMed 27670259

  • Shin W, Ham TY, Park YR, Lim MC, Won YJ. Comparing survival outcomes for cervical cancer based on the 2014 and 2018 International Federation of Gynecology and Obstetrics staging systems. Sci Rep. 2021 Mar 26;11(1):6988. doi: 10.1038/s41598-021-86283-2.

    PubMed 33772044

Questions about this trial

What is this clinical trial studying?

A study testing CCRT and Surgical debulking of lymph nodes + CCRT in people with Cervical Cancer, run by CHA University at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea, India, Italy, Romania, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ju-Won Roh (+82-31-782-8312, rohjuwon@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05421650, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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