KCT0007137Recruiting未知
Therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage IIICr: A phase III, randomized controlled clinical trial (DEBULK trial)
CHA University Ilsan Medical Center0 sites234 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 234
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 18(Year) to 70(Year) (—)
- Sex
- Female
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)
Investigators
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