Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer

NCT ID: NCT03356600

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2019-10-31

Brief Summary

To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients

Conditions

Brain Metastases

Keywords

Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib plus radiotherapy

Apatinib:

Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily.

After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg.

Radiotherapy:

The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy.

Group Type: EXPERIMENTAL

Apatinib plus radiotherapy

Intervention Type: COMBINATION_PRODUCT

Apatinib:

Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily.

After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg.

Radiotherapy:

The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy

Interventions

Apatinib plus radiotherapy

Apatinib:

Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily.

After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg.

Radiotherapy:

The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 75 years old, males or females;.

2. According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;

3. Subjects failed first-line standard chemotherapy ;

4. Subjects expected survival of more than 3 months;

5. Eastern Cooperative Oncology Group performance status :0-2 points;

6. The main organ function is normal, that is to meet the following standards:(1) Blood routine examination meets the following standards

a. Hemoglobin ≥90 g/L；b. Absolute Neutrophil Count≥1.5×10^9/L； c. Platelet ≥80×10^9/L； (2)Blood biochemistry examination meets the following standards

a.Total Bilirubin <1.5 times the upper normal limit；b.Glutamic transaminase <2.5 times the upper normal limit, glutamic-oxalacetic transaminase <2.5 times the upper normal limit， For patients with liver metastasis ,the Glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.Serum Cr was less than 1.25 times the upper normal limit

7. Women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.During the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception .

8. Subjects volunteered to participate in this study and signed informed consent

Exclusion Criteria

1. Patients with meningeal metastasis;

2. Patients with intracranial stroke;

3. Previous toxicity associated with chemotherapy and / or radiotherapy persisted;

4. Radiological evidence indicates the presence of an empty or necrotic tumor;

5. Radiological evidence indicates the presence of a central tumor invading large blood vessels;

6. Patients need to be treated with anticoagulants or antiplatelet drugs;

7. The subjects with abnormal coagulation function and bleeding tendency (INR>1.5×ULN、APTT>1.5×ULN);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;In the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency;

8. Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;

9. Other investigators believe that patients are not eligible for inclusion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanxi Province Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hongwei Li, Master Supervisor

Role: CONTACT

Phone: 13015301402

Email: ahead-sxzl7@hotmail.com

Other Identifiers

Ahead-SXZL 7

Identifier Type: -

Identifier Source: org_study_id