Clinical trial NCT05421650: Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
Official title: Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer IIICr
Bulky or multiple lymph nodes
Surgical debulking of lymph nodes
Concurrent chemoradiation therapy
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Korean Gynecologic Oncology Group
First posted: 2022-06-16
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

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)

Primary outcomes:
measure: PFS
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 3 years
measure: Treatment-related complications
timeFrame: 3 years
measure: False positive rate & positive predictive value of bulky or multiple LN imaging
timeFrame: 6 months
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Aster CMI Hospital
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chungcheongnam-do
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Medical Center
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangbuk-do
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Medical Center
state: Gyeongsangnam-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological & Medical Sciences
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu-si
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu-si
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
city: Targu Mures
country: Romania
facility: First Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
city: Ho Chi Minh City
country: Vietnam
facility: Ho Chi Minh City Oncology Hospital
Study officials:
affiliation: CHA University Ilsan Medical Center
name: Ju-Won Roh
role: PRINCIPAL_INVESTIGATOR
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