Overview

Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

Status:
Unknown status
Trial end date:
2019-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University
Treatments:
Endostar protein
Endostatins
Criteria
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/IVb by UICC2010 staging.

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.