RecruitingNot ApplicableNCT05421650
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial
Sponsor
CHA University
Enrollment
240 participants
Start Date
Aug 1, 2022
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 20 YearsMax Age: 70 Years
Inclusion Criteria1
- (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.
Exclusion Criteria1
- (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)
Interventions
OTHERCCRT
CCRT
PROCEDURESurgical debulking of lymph nodes + CCRT
Surgical debulking of lymph nodes + CCRT
Locations(26)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05421650
Related Trials
ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
NCT0697316127 locations
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
NCT049774538 locations
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
NCT06459180239 locations
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
NCT0721670360 locations
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
NCT0695266078 locations