NCT02471027

Brief Summary

This study is a registration study.The main research: the curative effect of neoadjuvant chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research group: the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control group:cervical cancer radical hysterectomy directly.Main observation indexes is overall survival and disease-free survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

May 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

4 years

First QC Date

May 28, 2015

Last Update Submit

June 11, 2015

Conditions

Cervical Cancer

Keywords

Locally advanced cervical cancerNeoadjuvant chemotherapyDisease-free survivalOverall survival

Outcome Measures

Primary Outcomes (1)

  • overall survival

    The time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up(In December 2019) still alive.

    The average time is up to four year.

Secondary Outcomes (1)

  • 3 year disease-free survival (DFS)

    The average time is up to three year.

Other Outcomes (4)

  • the quality of life assessment

    Before treatment and follow-up period.The average time is up to two year.

  • High risk factors of relapse analysis

    We get the result after operation.The average time is up to one year.

  • perioperative indexes

    The period of preoperative, intraoperative and postoperative.The average time is up to one year.

  • +1 more other outcomes

Study Arms (2)

Experimental group

2009 FIGO staging ⅠB2 or ⅡA2，the treatment is neoadjuvant chemotherapy combined with cervical cancer radical surgery .

Procedure: Neoadjuvant chemotherapy

control group

2009 FIGO staging ⅠB2 or ⅡA2，the treatment is cervical cancer radical surgery.

Interventions

Neoadjuvant chemotherapyPROCEDURE

There is no uniform schemer,commonly used drugs including carboplatin,cisplatin,paclitaxel,vincristine,bleomycin,fluorouracil,ifosfamide,mitomycin,gemcitabine,and so on.Methods including intravenous chemotherapy and artery intervention chemotherapy,also has not been unified.

Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.

You may qualify if:

  • Age greater than equal to 18
  • The initial treatment of cervical cancer,the Pathology is squamous cell carcinoma, adenocarcinoma and Adenosquamous carcinoma
  • FIGO clinical staging IB2, IIA2 stage cervical cancer
  • Patients acceptted the treatment of neoadjuvant chemotherapy combined cervical cancer radical surgery or cervical cancer radical surgery directly
  • Inform consent form

You may not qualify if:

  • With severe complications can not tolerate surgery, chemotherapy
  • Patients with distant metastasis
  • With uncontrolled seizures, central nervous system disease or a history of mental disorders, the researchers determine the clinical severity affect clinical research
  • The last five years has a history of other malignant diseases
  • Have received chemotherapy and radiotherapy patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen tissue and (or) whole blood

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Yu M Wu, professor

    Beijing obstetrics and geynecology hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu M Wu, professor

CONTACT

13701016571wym597118@163.com

Qun Zhao, Physician

CONTACT

18600964126qunzhao02@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

CN(1)