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Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02787447
Recruitment Status : Unknown
Verified November 2016 by First People's Hospital of Hangzhou.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : November 25, 2016
Information provided by (Responsible Party):
First People's Hospital of Hangzhou

Brief Summary:
The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma Drug: TKI Radiation: Thoracic Hypofractionated Radiotherapy Drug: Thymosin Alpha 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Hypofractionated Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.
Drug: TKI
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Erlotinib/Icotinib

Radiation: Thoracic Hypofractionated Radiotherapy
40-45 Gy/5-15f

Drug: Thymosin Alpha 1
Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.
Other Name: Zadaxin

Primary Outcome Measures :
  1. The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy [ Time Frame: 1-6 months ]
    To assess the proportion of patients with an abscopal response (defined as at least a 30% decrease in the longest diameter of the best responding abscopal lesion) at 1-6 months after the radiation therapy

Secondary Outcome Measures :
  1. To assess the short-term quality of life (QOL) [ Time Frame: 4 months ]
    FACT-E score at the 4 months after docetaxel consolidation therapy

  2. Rate of CTCAE grade 2 or higher radiation pneumonitis [ Time Frame: 1 years ]
    The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy

  3. Overall Survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy)
  • Age 18 years or older
  • ECOG Performance Status 0-2
  • Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal
  • For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
  • Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
  • Patients and their family signed the informed consents

Exclusion Criteria:

  • Received chemotherapy before TKI therapy
  • Brain parenchyma or leptomeningeal disease
  • Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment
  • Any medical co-morbidities that would preclude radiation therapy.

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 identifier (NCT number): NCT02787447

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Contact: Shenglin Ma, MD 0571-56007908 ext 086

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China, Zhejiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Shirong Zhang, Dr.    086057156007650   
Sponsors and Collaborators
First People's Hospital of Hangzhou
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Responsible Party: First People's Hospital of Hangzhou Identifier: NCT02787447    
Other Study ID Numbers: HZCH-2016-09
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Keywords provided by First People's Hospital of Hangzhou:
Hypofractionated Radiotherapy
Thymosin Alpha 1
Lung Adenocarcinoma
Tyrosine Kinase Inhibitors
Additional relevant MeSH terms:
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Adenocarcinoma of Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs