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RT Plus EGFR-TKI for Wild-type NSCLC

Primary Purpose

Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)
Radiotherapy
Sponsored by
Hangzhou Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), Radiotherapy, wild type

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. NSCLC confirmed by histopathology or cytology;
  2. Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
  3. Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  5. Expectancy life >= 3 months;

Exclusion Criteria:

  1. Had systemic anit-NSCLC treatments;
  2. Had be treated by HER-targeting agents;
  3. Had local radiotherapy for NSCLC;
  4. Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  5. Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  6. Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  7. Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
  8. Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
  9. Pregnancy or breast-feeding women;
  10. Ingredients mixed with small cell lung cancer patients;
  11. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.

Sites / Locations

  • Hangzhou Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bioradiotherapy

Arm Description

Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy).

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0).
Progression-free survival
Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Overall survival
Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.

Full Information

First Posted
April 4, 2016
Last Updated
April 11, 2016
Sponsor
Hangzhou Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02738983
Brief Title
RT Plus EGFR-TKI for Wild-type NSCLC
Official Title
Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
Keywords
Non-small cell lung cancer, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), Radiotherapy, wild type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bioradiotherapy
Arm Type
Experimental
Arm Description
Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy).
Intervention Type
Drug
Intervention Name(s)
Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)
Intervention Description
Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.
Primary Outcome Measure Information:
Title
Response rate
Time Frame
week 3-4
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
Description
Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0).
Time Frame
year 0- year 2
Title
Progression-free survival
Description
Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Time Frame
year 0- year 2
Title
Overall survival
Description
Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Time Frame
year 0- year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NSCLC confirmed by histopathology or cytology; Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy; Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm]; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; Expectancy life >= 3 months; Exclusion Criteria: Had systemic anit-NSCLC treatments; Had be treated by HER-targeting agents; Had local radiotherapy for NSCLC; Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD); Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation; Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection; Pregnancy or breast-feeding women; Ingredients mixed with small cell lung cancer patients; Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishuang Zheng, Dr
Phone
+8657186826086
Email
zhengzs19841130@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shixiu Wu, MD
Organizational Affiliation
Hangzhou Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhishuang Zheng
Email
zhengzs19841130@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

RT Plus EGFR-TKI for Wild-type NSCLC

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