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The Clinical Research of Neoadjuvant Chemotherapy Combined Surgery for Locally Advanced Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471027
Recruitment Status : Unknown
Verified June 2015 by Yu mei Wu, Capital Medical University.
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Collaborators:
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
Beijing Chao Yang Hospital
Beijing Anzhen Hospital
Beijing Shijitan Hospital
Peking University People's Hospital
Information provided by (Responsible Party):
Yu mei Wu, Capital Medical University

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.

Condition or disease Intervention/treatment
Cervical Cancer Procedure: Neoadjuvant chemotherapy

Detailed Description:

This study is a multicenter registered study.Selected January 1, 2009 to June 31,2016 ,accepted neoadjuvant chemotherapy combined radical surgery or radical surgery directly as treatment,ⅠB2 and ⅡA2 stage cervical cancer patients at each center to participate in research. Total number of patients is at least 1000 cases.On January 1, 2009 to May 31, 2015 ,collected the baseline data and follow-up information of hospitalized patients ,called a retrospective group.On June 1,2015 to May 31,2016,all the cases into the group take prospective way to collect baseline data (called a prospective group).Mainly collect the follow-up information.

1.The main observation indexes: the overall survival (OS) : 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 still alive(about four year).

2.Secondary outcome:

  1. 3 year disease-free survival (DFS) : from the operation time or neoadjuvant chemotherapy time calculation for the first time to recurrence/the time or the last follow-up time of death.
  2. the quality of life assessment: including EQ-5D health index scale and FSFI scale.
  3. the economics indexes: direct and indirect costs.
  4. High risk factors of the relapse analysis: lymph node positive rate, cervical local tumor changes after neoadjuvant chemotherapy, pathologic complete response rate after neoadjuvant chemotherapy, tumor pathology classification, tumor stromal infiltration depth, Cut edge positive rate, Vascular infiltration clearance rate, etc.
  5. perioperative: operation time, intraoperative blood loss, postoperative complications, postoperative mortality, infections, etc.
  6. adverse reactions (prospectie cohort study only) : application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions.

Subject of supervision organization for clinical research institute is Peking University Clinical Research Institute.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case Control
Target Follow-Up Duration: 4 Years
Official Title: Optimization Research of Early Cervical Caner Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
Experimental group
2009 FIGO staging ⅠB2 or ⅡA2,the treatment is neoadjuvant chemotherapy combined with cervical cancer radical surgery .
Procedure: Neoadjuvant chemotherapy
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.

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



Primary Outcome Measures :
  1. overall survival [ Time Frame: The average time is up to four year. ]
    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.


Secondary Outcome Measures :
  1. 3 year disease-free survival (DFS) [ Time Frame: The average time is up to three year. ]
    From the operation time or neoadjuvant chemotherapy time calculation for the first time to recurrence/the time of death or the last follow-up time.


Other Outcome Measures:
  1. the quality of life assessment [ Time Frame: Before treatment and follow-up period.The average time is up to two year. ]
    Including EQ-5D health index scale and FSFI scale.

  2. High risk factors of relapse analysis [ Time Frame: We get the result after operation.The average time is up to one year. ]
    The high risk factors of relapse contain:lymgh node positive rate, cervical local tumor changes after neoadjuvant chemotherapy, pathologic complete response rate neoadjuvant chemotherapy, tumor pathology classification, tumor stromal infiltration depth, Cut edge positive rate, Vascular tumor emboli rate, etc.

  3. perioperative indexes [ Time Frame: The period of preoperative, intraoperative and postoperative.The average time is up to one year. ]
    The perioperative indexes contain operation time, intraoperative blood loss, postoperative complications, postoperative mortality, etc.

  4. Adverse reactions [ Time Frame: The period of neoadjuvant chemotherapy and postoperative radiotherapy and chemotherapy.The average time is up to one year. ]
    Application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions.


Biospecimen Retention:   Samples With DNA
frozen tissue and (or) whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.
Criteria

Inclusion Criteria:

  1. Age greater than equal to 18
  2. The initial treatment of cervical cancer,the Pathology is squamous cell carcinoma, adenocarcinoma and Adenosquamous carcinoma
  3. 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer
  4. Patients acceptted the treatment of neoadjuvant chemotherapy combined cervical cancer radical surgery or cervical cancer radical surgery directly
  5. Inform consent form

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471027


Contacts
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Contact: Yu M Wu, professor 13701016571 wym597118@163.com
Contact: Qun Zhao, Physician 18600964126 qunzhao02@126.com

Locations
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China, Beijing
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Yu mei Wu
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
Beijing Chao Yang Hospital
Beijing Anzhen Hospital
Beijing Shijitan Hospital
Peking University People's Hospital
Investigators
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Principal Investigator: Yu M Wu, professor Beijing obstetrics and geynecology hospital
Additional Information:

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Responsible Party: Yu mei Wu, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier: NCT02471027    
Other Study ID Numbers: D151100001915001
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Yu mei Wu, Capital Medical University:
Locally advanced cervical cancer
Neoadjuvant chemotherapy
Disease-free survival
Overall survival
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female