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Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas) (Sindas)

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ClinicalTrials.gov Identifier: NCT02893332
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
ming zeng, MD, Sichuan Provincial People's Hospital

Brief Summary:
To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.

Condition or disease Intervention/treatment Phase
Stage IV EGFR Mutated Non-Small Cell Lung Cancer Radiation: Radiation: SBRT Drug: TKI (Gefitinib or Tarceva ) Phase 3

Detailed Description:

This protocol is a randomized phase III trial of TKI versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus TKI for patients with Stage IV non-small cell lung cancer (NSCLC).

Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with positive EGFR mutation. Patients who with fewer than or equal to 5 sites of oligometastatic disease will be randomized toTKI or consolidative SBRT to all sites of disease (followed by TKI at the medical oncologist's discretion). Choices of TKI will be determined by the medical oncologist based on clinical appropriateness.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Tyrosine-kinase Inhibitor (TKI) With or Without SBRT in Newly Diagnosed Advanced Staged Lung Adenocarcinoma
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: TKI without SBRT

Newly diagnosed Patients will be placed on EGFR-TKI, ,Gefitinib 250mg po qd or Tarceva 150mg po qd for their metastatic EGFR-mutant stage IV oligometastatic disease.

The oligometastatic disease will not receive SBRT

Drug: TKI (Gefitinib or Tarceva )
A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL, no local therapy apply to oligo-metastatic sites.

Experimental: TKI with SBRT

experimental: Oligometastatic Non-Small Cell Lung Cancer Newly diagnosed patients will be placed on EGFR-TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, and SBRT at the same time.

SBRT to up to 5 sites. The SBRT dose range from 5 Gy per fraction to 8 Gy per fraction. SBRT deliver within 5 fractions.

Radiation: Radiation: SBRT
A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL during a 1-week run-in period after which SBRT will be delivered to the all oligometastatic lesions concurrently with the TKI. The SBRT dose will be , ranging from at 25Gy (5 Gy per fraction) to 40 Gy (8 Gy per fraction).

Drug: TKI (Gefitinib or Tarceva )
A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL, no local therapy apply to oligo-metastatic sites.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 4 years ]
    Evaluate the effect of TKI with or without SBRT on progression free survival


Secondary Outcome Measures :
  1. local control [ Time Frame: 4 years ]
    To describe local control and out-of-field disease progression

  2. Overall survival [ Time Frame: 4 years ]
    To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion):

    • all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology
    • all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion.
  • Each brain metastasis is included as a distinct lesion.
  • Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib.
  • Lung adenocarcinoma histology confirmed
  • Karnofsky Performance Status ≥ 70%
  • 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) (except for patients with documented Gilbert's Syndrome)
    • 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

Exclusion Criteria:

  • Treatment with TKI prior to developing metastatic disease
  • Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR T790M)
  • Malignant pleural effusion or pleural disease
  • Leptomeningeal disease
  • Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy
  • Women who are breastfeeding or pregnant
  • Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment.
  • Any medical co-morbidities that would preclude surgery or 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 ClinicalTrials.gov identifier (NCT number): NCT02893332


Contacts
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Contact: Ming Zeng, MD PhD 00861708131336 miller2002@yahoo.acom
Contact: Ruilian Yu, MD 008617708130620 19986720@qq.com

Locations
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China, Sichuan
Sichuan PPH, Cancer Center Recruiting
Chengdu, Sichuan, China, 710062
Contact: Ming Zeng, MD PhD    008617708131336    miller2002@yahoo.com   
Contact: Ruilian Yu, MD    008617708130619    19986720@qq.com   
Sponsors and Collaborators
Sichuan Provincial People's Hospital
Investigators
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Study Chair: Ming Zeng, MD PhD Sichuan Provincial People Hospital

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Responsible Party: ming zeng, MD, Director of Cancer Center, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02893332     History of Changes
Other Study ID Numbers: 2016 15-1
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gefitinib
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action