Status:
UNKNOWN
Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Lead Sponsor:
Zhujiang Hospital
Conditions:
Neoplasms
Cervical Adenosquamous Cell Carcinoma
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous ce...
Detailed Description
This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclo...
Eligibility Criteria
Inclusion
- All volunteers will sign the informed consent.
- 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
- Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
- Prior invasive malignancy (except nonmelanomatous skin cancer)
- Contraindication of chemotherapy;
- Rare pathological subtype;
- Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03469531
Start Date
March 20 2018
End Date
December 30 2021
Last Update
August 13 2018
Active Locations (1)
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1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510282