NCT02950350

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

October 28, 2016

Last Update Submit

October 31, 2016

Conditions

Cervical Cancer, Stage IIBCervical Cancer Stage IIIACervical Cancer Stage IIIBCervical Cancer, Stage IVA

Keywords

Cervical cancerPrecision medicineIndividualized treatmentSurgical staging

Outcome Measures

Primary Outcomes (1)

  • The recurrence rate

    5 years after treatment

Secondary Outcomes (2)

  • The transfer rate

    5 years after treatment

  • mortality

    5 years after treatment

Study Arms (2)

radiation and chemotherapy

The patients will receive radiation and chemotherapy

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients from Dec 2016 until Dec 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.

You may qualify if:

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

You may not qualify if:

  • Underwent surgery or radiation and chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Xiaoqing Guo, PHD

    Shanghai First Maternity and Infant Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqing Guo, PHD

CONTACT

18117203488xiaoqingguo333@163.com

Na Liu, PHD

CONTACT

156017456991517693296@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 1, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2023

Last Updated

November 1, 2016

Record last verified: 2016-10