Clinical trial NCT02950350: Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer, Stage IIB
Cervical Cancer Stage IIIA
Cervical Cancer Stage IIIB
Cervical Cancer, Stage IVA
Keywords: Cervical cancer
Precision medicine
Individualized treatment
Surgical staging
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from Dec 2016 until Dec 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
* The pathological staging:IIB,IIIA,IIIB,IVA

Exclusion Criteria:

* Underwent surgery or radiation and chemotherapy

Primary outcomes:
measure: The recurrence rate
timeFrame: 5 years after treatment
Secondary outcomes:
measure: The transfer rate
timeFrame: 5 years after treatment
measure: mortality
timeFrame: 5 years after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai First Maternity and Infant Hospital
name: Xiaoqing Guo, PHD
role: PRINCIPAL_INVESTIGATOR
References: