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Stereotactic Radiosurgery (SRS) for Brain Metastasis (SRS)

This study is currently recruiting participants.
Verified December 2015 by University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02645487
First Posted: January 1, 2016
Last Update Posted: January 1, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.

Condition Intervention Phase
Brain Metastasis Radiation: Stereotactic Radiosurgery Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of Stereotactic Radiosurgery (SRS) for Brain Metastasis Without Whole Brain Radiation (WBRT)

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Maximal tolerated doses [ Time Frame: 90 days ]
    To identify the maximal tolerated doses for single-fraction stereotactic radiosurgery, within 90 days from the date of procedure, in patients with brain metastases who have not undergone prior brain irradiation.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ]
    To evaluate the overall survival (OS), which is defined as the time between date of SRS and the date of death due to any cause.

  • Time to progression [ Time Frame: 5 years ]
    To evaluate time to progression (TTP), which is defined as the time between date of SRS and date of documented progression. Specific TTP will be determined for the target lesion, non-target lesions, and elsewhere in brain.

  • Local progression rate [ Time Frame: 5 years ]
    To evaluate the local progression rate of the target lesion. Local progression will be defined by MRI imaging according to the modified RECIST 1.1 criteria. Suspected radiation necrosis and/or pseudoprogression will be similarly evaluate

  • Response rate [ Time Frame: 5 years ]
    To evaluate the response rate, consisting of complete response (CR) and partial response according to the modified RECIST 1.1.

  • Health-related quality of life [ Time Frame: 5 years ]
    To measure the improvement in health-related quality of life (HRQoL).

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: after 90 days up to 3 years ]
    To identify the chronic toxicity for single-fraction stereotactic radiosurgery, after 90 days up to 3 years from the date of procedure, in patients with brain metastases who have not undergone prior brain irradiation.

  • Age [ Time Frame: 1 month ]
    Age at diagnosis. This is one of the subgroup analysis

  • Performance status [ Time Frame: 5 years ]
    Initial and follow-up performance status. This is one of the subgroup analysis .

  • Number of metastases [ Time Frame: 5 years ]
    This is one of the subgroup analysis (e.g. single, 2-4 and 5-10 lesions)

  • Primary tumor histology [ Time Frame: 1 month ]
    This is one of the subgroup analysis

  • Tumor volume [ Time Frame: 1 month ]
    This is one of the subgroup analysis

  • Number of target volume receiving 12 Gy [ Time Frame: 1 month ]
    This is one of the subgroup analysis .

  • Number of patients treated with whole brain radiotherapy [ Time Frame: after protocol treatment SRS up to 5 years ]
    patients who are treated with whole brain radiotherapy after the protocol


Estimated Enrollment: 180
Study Start Date: December 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiosurgery
Radiation, Stereotactic Radiosurgery Dose-Escalation
Radiation: Stereotactic Radiosurgery
Radiation, Stereotactic Radiosurgery Size <= 1cm: 24 Gray (Gy); + 3 Gy incremental escalation up to 30 Gy >1-2cm: 21 Gy; + 3 Gy incremental escalation up to 27 Gy >2-3cm: 18 Gy; + 3 Gy incremental escalation up to 24 Gy >3-4cm: 15 Gy; + 3 Gy incremental escalation up to 21 Gy
Other Name: SRS

Detailed Description:

Recently, several large randomized studies have shown that in patients with limited brain metastases, whole brain radiation can be safely deferred when treated with SRS and close surveillance. In light of this, most of such patients are now treated with SRS alone without WBRT. However, the SRS doses set by Radiation Therapy Oncology Group (RTOG) 90-05 continue to be applied to patients without previous cranial irradiation.

The potential insufficiency of current SRS dose for long-term tumor control is of pressing concern. The advances chemotherapy has led to an improvement in overall survival in many patients with metastatic cancer, including malignancies often associated with brain metastases, such as lung (40-50%) and breast (15%). As these patients survive longer, more patients may develop brain metastases and the current dose of SRS may not be adequate to control the brain metastases for the duration of their survival. In fact, there is evidence that the control rate declines with time after SRS, and after 3 years, the local control rate may be only about 60%. In the case of brain metastases from relatively radio-resistant melanoma, the reported 12-months local control rates for SRS range from 52% to 75%. More potent SRS doses could lead to improved long-term control of brain metastases.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor.
  • Radiographic evidence by MRI of brain metastasis. (If patient is unable to tolerate contrast, an MRI without contrast is acceptable)
  • All brain metastases must be outside the brain stem (midbrain, pons and medulla).
  • Patient must have 10 or less brain metastases.
  • The maximum diameter of any lesion must be less than 4.0 cm.
  • Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that:

    • Systemic therapy was administered > 7 days before SRS
    • Radiation was not to the brain.
    • Surgery to the brain was > 7 days prior to SRS and there remains at least one additional brain metastasis that can be targeted with SRS
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 2 or better.
  • 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 protocol therapy.

    • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

      • Has not undergone a hysterectomy or bilateral oophorectomy; or
      • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Patients who have had chemotherapy, immunotherapy or any targeted therapy within 7 days prior to anticipated SRS treatment date or those planning for systemic therapy within 7 days following the protocol treatment.
  • Patients had craniotomy and surgery to the brain within 7 days from the date of SRS.
  • Patients with leptomeningeal metastasis.
  • Patients with a contraindication to MRI such as implanted metal devices or foreign bodies or severe claustrophobia.
  • Patients with life expectancy < 3 months.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients must not be pregnant at the time of SRS treatment.
  Contacts and Locations
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): NCT02645487


Contacts
Contact: Robert Timmerman, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Robert Timmerman, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert Timmerman, MD UTSW
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02645487     History of Changes
Other Study ID Numbers: STU 022015-106
First Submitted: December 30, 2015
First Posted: January 1, 2016
Last Update Posted: January 1, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases