Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
NCT ID: NCT03469531
Last Updated: 2018-08-13
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
PHASE2
100 participants
INTERVENTIONAL
2018-03-20
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
Nimotuzumab
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
Cisplatin
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
external-beam radiation
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
control group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
Cisplatin
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
external-beam radiation
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
Interventions
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Nimotuzumab
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
Cisplatin
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
external-beam radiation
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
* The FIGO stage (IIB-IVA) and was not available for surgical treatment.
* There is at least one tumor lesion that is measurable by RECIST.
* During the study, contraception should be ensured.
* Karnofsky performance status \>60.
* WBC \>= 3,000/mm\^3
* Absolute granulocyte count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* INR \< 1.5
* Total bilirubin =\< 1.5 mg/dL
* Serum creatinine =\< 1.5 mg/dL
* AST and ALT =\< 2.5 times upper limit of normal (ULN)
* Serum calcium =\< 1.3 times ULN
* Hemoglobin \>= 9g/dL (transfusion allowed)
Exclusion Criteria
* Prior invasive malignancy (except nonmelanomatous skin cancer)
* Contraindication of chemotherapy;
* Rare pathological subtype;
* Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.
18 Years
75 Years
FEMALE
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Principal Investigators
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junguo bu, doctor
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Locations
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Zhujiang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-ZLZX-002
Identifier Type: -
Identifier Source: org_study_id
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