Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer

Cervical Cancer Stage IIIB Clinical Trial

Official title:

Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02950350
• Other study ID #: Guo Xiaoqing
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2016
• Last updated: October 31, 2016
• Start date: December 2016
• Est. completion date: December 2023

Study information

• Verified date: October 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xiaoqing Guo, PHD
• Phone: 18117203488
• Email: xiaoqingguo333[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial Summary

Cervical cancer is the most common reproductive malignancy in developing country. Due to local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (FIGO IIB - IVA) , so that radiation combined with chemoradiation (RCTX) is a traditional treatment nowadays. Lack of precise treatment strategies, recurrent ratesand metastasisis high ,and the 5-year survival rate is less than 50%. Therefore, it needs to explore a new strategy for improving the prognosis of advanced cervical cancer.

The prognosis of cervical cancer is closely related to its stages ,while the current FIGO clinical stage is too subjective , for example different gynecologic oncologists may give different diagnosis to the same patient. MRI, CT, PET/CT imaging examinations are commonly used as a referrence for clinical staging, but the sensitivity and specificity are not satisfied. In addition, lymph node metastasis significantly impacts the prognosis of cervical cancer . However, the lymph node invasion is not in current staging criteria.

Precision treatment after surgical staging is recommended by NCCN recently .Surgical staging in patients with advancedcervical cancer is safe and does not delay primary RCTX in few randomized study.Whether overall survival benefit the long-term clinical follow-up surgical staging is unknown.Blocking bilateral uterine artery can effectively reduce the tumor size and increase the operability , which has been conformed in locally advanced cervical cancer. Furthermore, ovarian dysfunction caused by RCTX could be avoided by ovarian transposition via surgical staging .

Based on this, we suggesta new surgical stagingfor patients with advanced cervical cancer , which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel blocking and ovarian transportation, in order to perform individualized postoperative RCTX, reduce tumor load , preserve ovarian function and improve life quality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma

• The pathological staging:IIB,IIIA,IIIB,IVA

Exclusion Criteria:

• Underwent surgery or radiation and chemotherapy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer Stage IIIA
• Cervical Cancer Stage IIIB
• Cervical Cancer, Stage IIB
• Cervical Cancer, Stage IVA
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate		5 years after treatment	No
Secondary	The transfer rate		5 years after treatment	No
Secondary	mortality		5 years after treatment	No