Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with high efficacy and low toxicity.

Detailed Description
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This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Five medical centers participated in this study and 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and concurrent chemoradiotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.

Official Title
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A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Endostar
* Drug: DDP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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/IVb by UICC2010 staging. 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: concurrent chemoradiotherapy + endostar<br>Drug: Endostar Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy | Drug: Endostar<br>* intravenous infusion<br>* Other names: recombinant human endostatin;Drug: DDP<br> <br> |
| Active Comparator: concurrent chemoradiotherapy<br>Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy | Drug: DDP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year Progression Free Survival | The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year Overall Survival | The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, endostar, chemoradiotherapy