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

NCT03356600 | Unknown Phase 2 DMC

• 1 other identifier: Ahead-SXZL 7
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The intracranial disease progression free survival time

  To observe the intracranial disease progression free survival time of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients

  tumor assesment every 8 weeks,up to 24 months

Secondary Outcomes (11)

• Progression free survival time

  evaluated in 24 months since the treatment began

• Overall survival

  the first day of treatment to death or last survival confirm date ,up to 24 months

• Disease control rate

  tumor assesment every 8 weeks,up to 24 months

• Objective response rate

  tumor assesment every 8 weeks,up to 24 months

• Dosage changes of dexamethasone

  Dosage changes of dexamethasone every 8 weeks,up to 24 months

Study Arms (1)

Apatinib plus radiotherapy

EXPERIMENTAL

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.

Combination Product: Apatinib plus radiotherapy

Interventions

Apatinib plus radiotherapy 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

Apatinib plus radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years old, males or females;.
• According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;
• Subjects failed first-line standard chemotherapy ;
• Subjects expected survival of more than 3 months;
• Eastern Cooperative Oncology Group performance status :0-2 points;
• 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
• 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 .
• Subjects volunteered to participate in this study and signed informed consent

You may not qualify if:

• Patients with meningeal metastasis;
• Patients with intracranial stroke;
• Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
• Radiological evidence indicates the presence of an empty or necrotic tumor;
• Radiological evidence indicates the presence of a central tumor invading large blood vessels;
• Patients need to be treated with anticoagulants or antiplatelet drugs;
• 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;
• Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;

Sponsors & Collaborators

• Shanxi Province Cancer Hospital: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

apatinib; Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hongwei Li, Master Supervisor

CONTACT

13015301402; ahead-sxzl7@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 29, 2017
• Study Start: December 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 11, 2017

Record last verified: 2017-11