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

NCT02882984 | Unknown Phase 3 DMC

• 1 other identifier: Hybrid
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV EGFR Mutated NSCL With Brain Metastases

Outcome Measures

Primary Outcomes (1)

• iPFS

  intracranial progression-free survival

  18 months

Secondary Outcomes (2)

• cognitive function

  18 month

• Overall survival (OS)

  18 months

Study Arms (2)

WBRT along with TKI

ACTIVE COMPARATOR

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

HFSRS with EGFR TKI

EXPERIMENTAL

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

Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib; Radiation: HFSRS

Interventions

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

radiation given along with one of kind TKI

Also known as: EGFR-TKI

HFSRS with EGFR TKI; WBRT along with TKI

WBRT RADIATION

3750 cGy in 15 fractions given within 3 weeks time.

WBRT along with TKI

HFSRS RADIATION

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.

HFSRS with EGFR TKI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan PPH, Cancer Center

Chengdu, Sichuan, 710062, China

RECRUITING

MeSH Terms

Interventions

Gefitinib; Erlotinib Hydrochloride; icotinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ming Zeng, MD PhD

  Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

YiFeng Bai, MD PhD

CONTACT

008618183298718; 15756285949@qq.com

ming zeng, MD PhD

CONTACT

17708131336; miller2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

CN (1)