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

• Conditions: Cervical Cancer
• Interventions: Procedure: Neoadjuvant chemotherapy

• Registration Number: NCT02471027
• Lead Sponsor: Yu mei Wu

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.

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 Timeline

• Study First Submitted: 2015-05-28
• Status Verified: 2015-06
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-11
• Last Update Submitted: 2015-06-11
• Study First Posted: 2015-06-12
• Last Update Posted: 2015-06-12
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
overall survival	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

Name	Time	Method
3 year disease-free survival (DFS)	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.

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China