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

NCT ID: NCT02950350

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer, Stage IIB Cervical Cancer Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer, Stage IVA

Keywords

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Cervical cancer Precision medicine Individualized treatment Surgical staging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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radiation and chemotherapy

The patients will receive radiation and chemotherapy

No interventions assigned to this group

removal of pelvic lymph nodes and abdominal aorta lymph nodes

The patients will receive removal of pelvic lymph nodes and abdominal aorta lymph nodes ,and receive concurrent radiation and chemotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Underwent surgery or radiation and chemotherapy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoqing Guo, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai First Maternity and Infant Hospital

Central Contacts

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Xiaoqing Guo, PHD

Role: CONTACT

Phone: 18117203488

Email: [email protected]

Na Liu, PHD

Role: CONTACT

Phone: 15601745699

Email: [email protected]

Other Identifiers

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Guo Xiaoqing

Identifier Type: -

Identifier Source: org_study_id