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

Primary Purpose

Stage IV EGFR Mutated NSCL With Brain Metastases

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib

WBRT

HFSRS

About this trial

This is an interventional treatment trial for Stage IV EGFR Mutated NSCL With Brain Metastases

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sichuan PPH, Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

WBRT along with TKI

HFSRS with EGFR TKI

Arm Description

Drug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 3750Gy/15F Other Name: WBRT

Drug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 25 to 40 Gy/5F Other Name: HFSRS

Outcomes

Primary Outcome Measures

iPFS

intracranial progression-free survival

Secondary Outcome Measures

cognitive function

Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination

Overall survival (OS)

Overall survival

Full Information

NCT ID

NCT02882984

First Posted

August 25, 2016

Last Updated

August 29, 2016

Sponsor

Sichuan Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02882984

Brief Title

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

Acronym

Hybrid

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan Provincial People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV EGFR Mutated NSCL With Brain Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

325 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WBRT along with TKI

Arm Type

Active Comparator

Arm Description

Drug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 3750Gy/15F Other Name: WBRT

Arm Title

HFSRS with EGFR TKI

Arm Type

Experimental

Arm Description

Drug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 25 to 40 Gy/5F Other Name: HFSRS

Intervention Type

Drug

Intervention Name(s)

Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib

Other Intervention Name(s)

EGFR-TKI

Intervention Description

radiation given along with one of kind TKI

Intervention Type

Radiation

Intervention Name(s)

WBRT

Intervention Description

3750 cGy in 15 fractions given within 3 weeks time.

Intervention Type

Radiation

Intervention Name(s)

HFSRS

Intervention Description

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.

Primary Outcome Measure Information:

Title

iPFS

Description

intracranial progression-free survival

Time Frame

18 months

Secondary Outcome Measure Information:

Title

cognitive function

Description

Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination

Time Frame

18 month

Title

Overall survival (OS)

Description

Overall survival

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

YiFeng Bai, MD PhD

Phone

008618183298718

15756285949@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

ming zeng, MD PhD

Phone

17708131336

miller2002@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Zeng, MD PhD

Organizational Affiliation

Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Sichuan PPH, Cancer Center

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

710062

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yifeng Bai, MD PhD

Phone

18183298718

15756285949@qq.com

First Name & Middle Initial & Last Name & Degree

Ming zeng, MD PhD

Phone

008617708131336

miller2002@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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