Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)

Stage IV EGFR Mutated NSCL With Brain Metastases Clinical Trial

— Hybrid  

Official title:

Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882984
• Other study ID #: Hybrid
• Status: Recruiting
• Phase: Phase 3
• First received: August 25, 2016
• Last updated: August 29, 2016
• Start date: March 2015
• Est. completion date: December 2020

Study information

• Verified date: August 2016
• Source: Sichuan Provincial People's Hospital
• Contact: YiFeng Bai, MD PhD
• Phone: 008618183298718
• Email: 15756285949[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial Summary

A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive function, quality of life (QoL) and adverse events.

Description:

WBRT remains to be standard of care for NSCL patients. Long term survival from WBRT may have noticeable cognitive dysfunction. The EGFR TKI has reasonable control for intracranial disease, but the duration of EGFR TKI control disease is variable due to tendency of drug resistance. To maintain intracranial disease control and improve cognitive function, the investigators propose using hypofractionated SRS in multiple brain metastases or large brain lesions alone with TKI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: December 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Histological or cytological confirmation of non-small cell lung cancer (NSCLC);

• Diagnosis of brain metastases on a Gadolinium-enhanced MRI.

• More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 4 cm.

• Positive EGFR mutation.

• Life expectancy =3months.

• Have one or more measurable encephalic lesions according to RECIST.

• Adequate hematological function: Absolute neutrophil count (ANC) =1.5 x 109/L, and Platelet count =100 x 109/L.

• Adequate renal function: Serum creatinine =1.5 x ULN, or = 50 ml/min.

• Adequate liver function: Total bilirubin = 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

• Female subjects should not be pregnant.

• All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

• Written informed consent provided.

Exclusion Criteria:

• Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.

• CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

• Allergic to Icotinib.

• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

• Pregnancy or breast-feeding women.

• Participate in the other anti-tumor clinical trials in 4 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Stage IV EGFR Mutated NSCL With Brain Metastases

Intervention

Drug:
• Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib
radiation given along with one of kind TKI

Radiation:
• WBRT
3750 cGy in 15 fractions given within 3 weeks time.
• HFSRS
All HFSRS given in 5 fractions. dose per fraction ranges from 5 to 8 Gy depending on the target volume and organs at risk tolerance.

Locations

Country	Name	City	State
China	Sichuan PPH, Cancer Center	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iPFS	intracranial progression-free survival	18 months	No
Secondary	cognitive function	Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination	18 month	No
Secondary	Overall survival (OS)	Overall survival	18 months	No