Clinical Trial - NCT02314364

A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Henning Willers, M.D. Principal Investigator

ClinicalTrials.gov Identifier: NCT02314364

Protocol Info

Short Description: A Phase 2 of Stereotactic Body Radiation Therapy with Targeted Therapy in Stage IV Oncogene-driven NSCLC
Long Description: A Phase II Trial of Integrating Stereotactic Body Radiation Therapy with Selective Targeted Therapy in Stage IV Oncogene-driven Non-Small Cell Lung Cancer
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


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Purpose

This research study is studying a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced anaplastic lymphoma receptor tyrosine kinase (ALK) or ROS proto-oncogene 1 (ROS1) gene (= oncogene-driven NSCLC) and for which the subject has been receiving treatment with a targeted biological agent such as erlotinib, crizotinib, or other drugs.
Condition Title Intervention Phase
Non-small Cell Lung Cancer Metastatic Targetable Oncogenes (EGFR, ALK, ROS1) SBRT with protons or photons Phase 2
Study Type Interventional
Official Title A Phase II Trial of Integrating Stereotactic Body Radiation Therapy With Selective Targeted Therapy in Stage IV Oncogene-driven Non-Small Cell Lung Cancer

Primary Outcome Measures

Frequency of distant failures (DF) after SBRT [Time Frame: 12 months] [Designated as safety issue: ]


Secondary Outcome Measures

Number of Participants with Adverse Events [Time Frame: Up to 2 years] [Designated as safety issue: ]

Progression Free Survival [Time Frame: Duration of time from documented start of TKI therapy to time of progressive disease, assessed up to 5 years.] [Designated as safety issue: ]

Overall Survival [Time Frame: Duration of time from the start of documented TKI therapy for up to 5 years or until time of death, whichever occurs first.] [Designated as safety issue: ]

Pattern of original and distant site failures (OF and DF) [Time Frame: 2 Years] [Designated as safety issue: ]

Local control of lesions treated with SBRT [Time Frame: The duration of LC is defined as the time period between the completion of SBRT to the time of objective progressive disease, assessed up to 5 years.] [Designated as safety issue: ]

Estimated Enrollment: 30
Study Start Date: December 2014
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021
Arms Assigned Interventions

Experimental:SBRT with protons or photons

Dosage determined by treating physician If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
Radiation:SBRT with protons or photons

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with any actionable mutation or translocation in EGFR, ALK, or ROS1
  • Stage IV disease (AJCC Staging system 7th edition)
  • Within 6 months of initiating their first TKI treatment regimen
  • Stable or responding systemic disease to TKI (no evidence of progression) on the most recent staging studies. The complete extent of the current residual systemic disease must be deemed amenable to SBRT as per review of imaging studies by a radiation oncologist, based on the following criteria:
  • Lung: 1-3 lesions (including the primary) of maximum size 5 cm in longest diameter. A minimum size 1 cm in the longest diameter is recommended. (Patients with a malignant pleural effusion prior to the start of TKI therapy will be considered eligible for SBRT if there is complete radiographic resolution of the effusion while on systemic therapy);
  • Spine: Bone lesions must be limited to the spine. A maximum of 2 spinal metastases will be considered for SBRT, with each site spanning 1-3 vertebral bodies. A minimum size of 1 cm in longest diameter is recommended. SBRT may target sclerotic lesions that persist following TKI therapy;
  • GI: 1-4 liver metastases of maximum size 5 cm in longest diameter and/or 1-2 adrenal metastases of maximum 4 cm size in longest diameter. A minimum size of 1 cm in longest diameter is recommended.

In addition:

  • CNS: 1-4 brain metastases of maximum size 3cm in longest diameter. However, these should be treated with standard-of-care SRS and will not be defined as target lesions for purposes of this protocol.
  • A maximum number of 5 target lesions outside the brain, excluding the lung primary, is recommended to ensure that enrollment is limited to patients with low-burden disease and that treatments can be delivered within the specified time frame.
  • History of prior radiation therapy to brain or skeleton is allowed, but should have occurred > 2 months from enrollment.
  • Age at least 18 years.
  • Life expectancy of greater than 6 months.
  • ECOG performance status ≤ 2.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative serum or urine pregnancy test within 2 weeks of registration for women of childbearing potential is required.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Residual hilar or mediastinal lymph node disease (size > 1cm in short-axis diameter on CT). Non-malignant etiologies for enlarged lymph nodes may be evaluated per standard clinical practice.
  • Participants who have received prior radiation therapy to anatomical sites other than brain or skeleton.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who are pacemaker or defibrillator-dependent as these devices may not be operated concurrently with delivery of proton beam radiation.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02314364

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Henning Willers, M.D. Principal Investigator
ClinicalTrials.gov Identifier: NCT02314364
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Non-small cell lung cancer

Metastatic

EGFR

ALK

ROS1

Stereotactic Body Radiation Therapy

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019