Clinical trial NCT02471027: The Clinical Research of Neoadjuvant Chemotherapy Combined Surgery for Locally Advanced Cervical Cancer
Official title: Optimization Research of Early Cervical Caner Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: Locally advanced cervical cancer
Neoadjuvant chemotherapy
Disease-free survival
Overall survival
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University Third Hospital
name: Chinese PLA General Hospital
name: Beijing Chao Yang Hospital
name: Beijing Anzhen Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Peking University People's Hospital
First posted: 2015-06-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.

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.

Eligibility 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

Primary outcomes:
measure: overall survival
timeFrame: The average time is up to four year.
Secondary outcomes:
measure: 3 year disease-free survival (DFS)
timeFrame: The average time is up to three year.
Other outcomes:
measure: the quality of life assessment
timeFrame: Before treatment and follow-up period.The average time is up to two year.
measure: High risk factors of relapse analysis
timeFrame: We get the result after operation.The average time is up to one year.
measure: perioperative indexes
timeFrame: The period of preoperative, intraoperative and postoperative.The average time is up to one year.
measure: Adverse reactions
timeFrame: The period of neoadjuvant chemotherapy and postoperative radiotherapy and chemotherapy.The average time is up to one year.
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing obstetrics and geynecology hospital
name: Yu M Wu, professor
role: PRINCIPAL_INVESTIGATOR
References: