Therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage IIICr: A phase III, randomized controlled clinical trial (DEBULK trial)

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0007137
• Lead Sponsor: CHA University Ilsan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

(1) Women =20 years and = 70 years of age
(2) Newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
(3) When the radiology examinations such as CT, MRI, or PET-CT show the short-axis of the pelvic LN or paraaortic LN under the renal vein is = 2cm, or more than 3 LNs with a short axis = 1 cm
(4) When CCRT is planned as a treatment for cervical cancer
(5) A patient whose competency is ECOG performance score 0-1
(6) A patient which has signed the approved informed consent form for study subjects
(7) A patient for which it is determined that surgical debulking is possible for LN metastasis as confirmed by radiological examination

Exclusion Criteria

(1) A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years
(2)A patient that is pregnant or plans to become pregnant during the clinical study period
(3)A patient with any active infectious disease or incurable severe inflammation.
(4)When surgery is not possible due to internal or surgical disease
(5)When chemotherapy is impossible due to internal or surgical disease
(6)A patient with a history of pelvic radiation therapy
(7)A patient with a history of subtotal hysterectomy
(8)A patient with a remote metastasis other than a pelvic lymph node or paraaortic lymph node (Ex. Lung, subclavian lymph node, inguinal lymph node)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year progression-free survival (PFS) and 3-year overall survival (OS)

Secondary Outcome Measures

Name	Time	Method
Treatment-related complications;Measurement of imaging accuracy of bulky or multiple lymph nodes