Nasopharyngeal Carcinoma
Conditions
Keywords
Endostar, Radiation-induced Brain Necrosis, Nasopharyngeal Carcinoma
Brief summary
To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. detailed description:
Detailed description
This was a single-arm, open-label study. We aimed to evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. Magnetic resonance imaging (MRI) was performed pre- and post-treatment to define the radiographic response.The primary outcome was a 2-month response rate as determined by MRI and clinical symptoms. All of the patients were followed up with for 6 months.
Interventions
DRUGEndostar
Endostar: 210 mg (14 PCS) continuous infusion for 168h, Q3W, 4 cycles. Methylprednisolone: 80mg intravenously, once daily, for 3-5 days, gradually reduced to 10mg/ day oral maintenance dose.
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cytologically or histologically proven Nasopharyngeal Carcinoma(WHO 2003 I-III) . * Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region; * age ≥18 years; * radiation therapy history for histologically confirmed NPC administered≥6 months prior to study entry; * radiographic evidence to support the diagnosis of RN with out tumor recurrence or metastases; * patients had never received Antiangiogenic agents for RN treatment prior to the screening; * patients had never received corticosteroids for RN treatment prior to the screening; * no evidence of very high intracranial pressure suggestive of a brain hernia requiring surgery routine laboratory studies including urinalysis, complete blood count, liver function, renal function, and coagulation test within a normal range; * to understand and be willing to sign a written informed consent.
Exclusion criteria
* Other types of Nasopharyngeal Carcinoma; * Recurrent nasopharyngeal carcinoma, resection of encephalopathy, metastasis, hepatitis, other malignant tumors, neurovascular diseases, or other diseases of the nervous system; * Inadequately controlled diabetes (FBG \> 10mmol/L) and hypertension(systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); * Other severe concurrent disorders that occurred before enrollment (severe or unstable angor, NYHA class 3 or 4 congestive heart failure, Myocardial infarction occurred within 6 months before enrollment；Aortic dissection aortic aneurysm.) active central nervous system hemorrhage; * pregnant or lactating women, women who have not undergone a pregnancy test (within 14 days prior to initial administration), and pregnant women; * Patients with a history of severe mental illness or communication disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | All of the patients were followed up with for 6 months. | 2-month response rate as determined by MRI and clinical symptoms |
Countries
China
Outcome results
None listed