Status:
COMPLETED
Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A total of 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60 patients in each group. One ...
Detailed Description
This study was a multicenter, open-label, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, c...
Eligibility Criteria
Inclusion
- patients of either gender and aged from 18 to 70 years old.
- patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
- patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded.
- KPS ≥ 70 (Appendix I)
- patients with available MRI data of nasopharynx and measurable tumor lesions.
- patients did not receive any treatment before enrollment.
- patients with expected survival longer than 6 months.
- biochemical indexes: hemoglobin \> 120 g/L, WBC \> 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 folds of the upper limit of normal value.
- the informed content was obtained from every patient.
- patients with effective follow-up.
Exclusion
- those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
- those received treatments before enrollment.
- pregnant or lactating women and reproductive women without contraception.
- those who were undergoing other drug trials.
- those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
- those who could not be followed up at regular intervals.
- those who were treated with tumor targeting drugs.
- those who could not subject to MRI examination.
- those who could not meet the requirements of the prescribed dose.
- those with hemorrhagic tendency.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02237924
Start Date
September 1 2014
End Date
January 1 2022
Last Update
February 14 2022
Active Locations (1)
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1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021