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

Optimization Research of Early Cervical Caner Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Yu M Wu, professor; Phone Number: 13701016571; Email: wym597118@163.com
• Study Contact Backup: Name: Qun Zhao, Physician; Phone Number: 18600964126; Email: qunzhao02@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 year disease-free survival (DFS)	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.	The average time is up to three year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the quality of life assessment	Including EQ-5D health index scale and FSFI scale.	Before treatment and follow-up period.The average time is up to two year.
High risk factors of relapse analysis	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.	We get the result after operation.The average time is up to one year.
perioperative indexes	The perioperative indexes contain operation time, intraoperative blood loss, postoperative complications, postoperative mortality, etc.	The period of preoperative, intraoperative and postoperative.The average time is up to one year.
Adverse reactions	Application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions.	The period of neoadjuvant chemotherapy and postoperative radiotherapy and chemotherapy.The average time is up to one year.

Collaborators and Investigators

• Sponsor: Yu mei Wu
• Collaborators: Peking University First Hospital; Peking University People's Hospital; Chinese PLA General Hospital; Peking University Third Hospital; Beijing Chao Yang Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Anzhen Hospital
• Investigators: Principal Investigator: Yu M Wu, professor, Beijing obstetrics and geynecology hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Estimate): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Neoadjuvant chemotherapy; Overall survival; Disease-free survival; Locally advanced cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: D151100001915001