The clinical trial to increase the cure rate for advanced cervical cancer with lymph node metastasis

Phase 3

Conditions: Health Condition 1: C56- Malignant neoplasm of ovary

Registration Number: CTRI/2024/05/066695

Lead Sponsor: Korean Gynecologic Oncology Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

(1) Women =20 years and = 70 years of age

1) Newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

2) 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 3 or more LNs with a short axis = 1 cm

3) When CCRT is planned as a treatment for cervical cancer

4) A patient whose competency is ECOG performance score 0-1

5) A patient which has signed the approved informed consent form for study subjects

6) 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

(7)A patient with a remote metastasis (e.g., lung, supraclavicular lymph node,inguinal lymph node, etc.) other than a pelvic lymph node or paraaortic lymph node metastasis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is to check the progression-free survival rateTimepoint: Starting from baseline,(after patient registration) for up to 3 years after the patient is registered.

Secondary Outcome Measures

Name	Time	Method
- To compare treatment-related complicationsTimepoint: 1-4 years;- To evaluate the diagnostic accuracy of imaging examination for the diagnosis <br/ ><br>of bulky LNs or multiple LNsTimepoint: 1-4 years