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TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

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ClinicalTrials.gov Identifier: NCT03916913
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jingbo Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary:
In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Metastatic Radiation: Local radiation therapy Not Applicable

Detailed Description:
Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Local therapy
Consolidation local radiotherapy
Radiation: Local radiation therapy
Local radiotherapy on all sites of disease including primary and metastatic lesions




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 1 year ]
    Duration between the first date of TKI administration and disease progression or last follow-up


Secondary Outcome Measures :
  1. Overall response [ Time Frame: 1 month after RT ]
    Post-RT response compared with the baseline status at the first data of TKI administration

  2. Overall survival [ Time Frame: 2 year ]
    Duration between the first date of TKI administration and any cause of death or last follow up

  3. Time to progression of initial lesions [ Time Frame: 1 year ]
    Duration between the first date of TKI administration and the progression of the initial lesions or last follow up

  4. Time to appearance of new metastatic lesions [ Time Frame: 1 year ]
    Duration between the first date of TKI administration and the occurrence of new lesions or last follow up

  5. Treatment related toxicity [ Time Frame: 1 year ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  6. EORTC Quality of life [ Time Frame: 1 year ]
    Quality of life evaluation using EORTC questionnaires



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 and ≤75;
  • ECOG performance status 0-1;
  • Patients must provide study specific informed consent prior to study entry;
  • Pathologically or cytologically diagnosed as NSCLC;
  • EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;
  • Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication;
  • Patients have received≥3 months of TKI therapy and do not received disease progression;
  • HB ≥ 10.0 g/dL;
  • Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L;
  • Absolute number of PLT ≥ 100 × 109/L;
  • Total bilirubin ≤ 1.5 folds of the maximum extent;
  • ALT and AST ≤ 2.0 folds of the maximum extent;
  • Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min.

Exclusion Criteria:

  • Patients have received thoracic radiotherapy before;
  • Malignant pleural effusion, pericardial effusion or peritoneal effusion;
  • Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;
  • Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication,hepatic, nephric or metabolic disease;
  • HIV infection;
  • Pregnancy or lactation women;
  • ECOG status ≥2;
  • Mixed SCLC component;
  • Other factors that is considered ineligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916913


Contacts
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Contact: Jingbo Wang, MD +861087788056 wangjingbo303@yahoo.com
Contact: Xiaotong Lu, MD +861087788503 lxt0115@126.com

Locations
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China, Beijing
Cancer Hospital/Institute, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Jingbo Wang, Dr.    8610-87788503    wangjingbo303@yahoo.com   
Contact: Luhua Wang, Dr.    8610-87788799    wlhwq@yahoo.com   
Principal Investigator: Jingbo Wang, Dr.         
Sub-Investigator: Luhua Wang, Dr.         
Sub-Investigator: Zhouguang Hui, Dr.         
Sub-Investigator: JianYang Wang, Dr.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Jingbo Wang, MD Cancer Hospital, CAMS

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Responsible Party: Jingbo Wang, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03916913     History of Changes
Other Study ID Numbers: NCC201805002
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jingbo Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Non small cell lung cancer
Oligo-metastasis
EGFR activating mutation
Radiotherapy

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms