Cervical Cancer Clinical Trial
Official title:
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.
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.
;
Observational Model: Case Control
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