The Clinical Research of Neoadjuvant Chemotherapy Combined Surgery for Locally Advanced Cervical Cancer
NCT ID: NCT02471027
Last Updated: 2015-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2015-06-30
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
Study Groups
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Experimental group
2009 FIGO staging ⅠB2 or ⅡA2，the treatment is neoadjuvant chemotherapy combined with cervical cancer radical surgery .
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Peking University First Hospital
OTHER
Peking University Third Hospital
OTHER
Chinese PLA General Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Beijing Anzhen Hospital
OTHER
Beijing Shijitan Hospital, Capital Medical University
OTHER
Peking University People's Hospital
OTHER
Yu mei Wu
OTHER
Responsible Party
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Yu mei Wu
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Principal Investigators
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Yu M Wu, professor
Role: PRINCIPAL_INVESTIGATOR
Beijing obstetrics and geynecology hospital
Locations
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Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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D151100001915001
Identifier Type: -
Identifier Source: org_study_id
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