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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02237924 |
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Date of registration:
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09/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma
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Scientific title:
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Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma. |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02237924 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Sheng ren Wang, doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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First Affiliated Hospital of Guangxi Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. patients of either gender and aged from 18 to 70 years old.
2. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal
carcinoma.
3. patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors
(such as N3 and T4N2) were excluded.
4. KPS = 70 (Appendix I)
5. patients with available MRI data of nasopharynx and measurable tumor lesions.
6. patients did not receive any treatment before enrollment.
7. patients with expected survival longer than 6 months.
8. 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.
9. the informed content was obtained from every patient.
10. patients with effective follow-up.
Exclusion Criteria:
1. those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma
skin cancer, and cervical carcinoma in situ.
2. those received treatments before enrollment.
3. pregnant or lactating women and reproductive women without contraception.
4. those who were undergoing other drug trials.
5. those with severe complications, including myocardial infarction, severe arrhythmia,
severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable
diabetes.
6. those who could not be followed up at regular intervals.
7. those who were treated with tumor targeting drugs.
8. those who could not subject to MRI examination.
9. those who could not meet the requirements of the prescribed dose.
10. those with hemorrhagic tendency.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nasopharyngeal Carcinoma
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Intervention(s)
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Radiation: IMRT
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Drug: DDP
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Drug: endostar
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Primary Outcome(s)
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5-year Overall Survival
[Time Frame: 6 years]
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Secondary Outcome(s)
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3-year Progression Free Survival
[Time Frame: 4 years]
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Secondary ID(s)
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S201413__19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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