Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
Study Details
Study Description
Brief Summary
To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients.
detailed description:
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Endostar combined with Methylprednisolone Endostar combined with Methylprednisolone lasts for 10 weeks |
Drug: Endostar
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- ORR [All of the patients were followed up with for 6 months.]
2-month response rate as determined by MRI and clinical symptoms
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Xiaochang Gong | Nanchang | Jiangxi | China | 330000 |
Sponsors and Collaborators
- Jiangxi Provincial Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NPC-RN-001