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Trial record 1 of 1 for:    NCT04040400
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Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection

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ClinicalTrials.gov Identifier: NCT04040400
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shiao Yuo Woo, University of Louisville

Tracking Information
First Submitted Date  ICMJE July 20, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE October 23, 2019
Estimated Primary Completion Date July 15, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • Established Maximum tolerated dose [ Time Frame: Phase I cohorts; 90 days from treatments ]
    Maximum tolerated dose will be determined by classical 3+3 dose-escalation design. Toxicity will be measured using the National Cancer Institute Common terminology criteria for adverse events (version 5.0). The first dose of 18Gy will be administered to the first 3 subjects, after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if the next 3 subject will escalation to dose of 21Gy or receive 18Gy. If escalation to 21Gy is permitted, then after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if next cohort of 3 subjects will escalate to a dose of 24Gy or receive 21Gy. The highest dose level to be administered will be 24 Gy if permitted by safety assessments.
  • Final Overall survival [ Time Frame: through study completion, an average of 10 years ]
    Kaplan-Meier methods and the log-rank test will be used to estimate survival outcomes including overall survival.
  • Recurrence rate of treated brain metastasis [ Time Frame: through study completion, an average of 10 years ]
    Multivariable Cox regression will be used to evaluate prognostic factors associated with survival.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04040400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Functional Assessment of Cancer Therapy-Brain (FACT-Br) [ Time Frame: through study completion, an average of 10 years ]
The Questionnaire Functional Assessment of Cancer Therapy (FACT) is a self-reported quality of life questionnaire that includes 27 items. The brain tumor specific version, is an additional 23-item sub-scale set of disease-specific questions pertaining to brain neoplasms. Patients rate each question using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Item areas are: physical well-being, social/family well-being, emotional well-being, functional well-being and sub-scale item area relevant to patients with brain tumors. Overall, higher ratings suggest higher Quality of Life score. Items are totaled (summed) to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
Quality of Life Assessment: Questionnaire Functional Assessment of Cancer Therapy (FACT)-Brain [ Time Frame: through study completion, an average of 10 years ]
Questionnaire used to assess cancer-related quality of life issues. The Questionnaire Functional Assessment of Cancer Therapy (FACT)-Brain version provides an additional set of disease-specific questions pertaining to brain neoplasms.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
Official Title  ICMJE A Phase I/II Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
Brief Summary The primary purpose of this study is to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT) following neurosurgical resection for large brain metastases, and to determine the progression-free survival rate as in the recurrence rate of treated brain metastasis.
Detailed Description The potential for delivering ablative doses of radiation to the tumor bed while simultaneously sparing normal brain parenchyma from significant doses of radiation and reducing the potential for tumor repopulation has led to interest in the use of intraoperative radiotherapy (IORT) for brain metastasis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:

The resection procedure should be performed with image guidance (neuronavigation) with standard surgical technique.

Optimal balloon applicator size will be selected with accordance to tumor bed/cavity geometry and adjacent normal brain parenchyma by the team of surgeons and radiation oncologists.

The radiation oncologist will place the miniature x-ray source inside the balloon shaped catheter placed inside the tumor cavity. Radiotherapy will be initiated by the treating radiation oncologist for a defined time interval calculated by the machine planning software.

After IORT has been delivered, the surgeon will remove the balloon applicator. Surgery will be continued in the regular fashion without additional requirements.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE Device: intraoperative radiotherapy (IORT)
intraoperative radiotherapy (IORT) during brain tumor resection
Study Arms  ICMJE Experimental: Treatment Arm
intraoperative radiotherapy (IORT) arm
Intervention: Device: intraoperative radiotherapy (IORT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2034
Estimated Primary Completion Date July 15, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants must be ≥ 18 years of age.
  2. Participants must have a Karnosfky performance status of ≥ 50%.
  3. Participants must not have had prior intracranial radiation.
  4. Participants must have a life expectancy greater than 3 months.
  5. Participants must have a preoperative MRI Brain T1-Gadolinum enhanced scan demonstrating a non-dural based lesion with greatest diameter ≥ 2.5 cm.
  6. Sufficient distance (≥ 2cm) of the intracranial lesion from optic structures (optic chiasm and bilateral optic nerves) and brainstem to meet established normal structure dose limits.
  7. Subject or subject's legal representative to provide signed/written informed consent to participate in the study protocol.
  8. Surface of balloon applicator must be ≥ 1cm from skin overlying closest portion of calvarium.
  9. Participants may remain on systemic therapy if they are receiving immunotherapy (anti-PD1, anti-PDL1, anti-CTLA-4), capecitabine, temozolomide, etoposide, vinorelbine, pemetrexed, lapatinib, traztuzumab, bevacizumab, mTor or ALK targeted agents with no break prior to initiating IORT.

9.1 Participants receiving cisplatin, methotrexate, taxanes, tyrosine kinase inhibitors, or BRAF targeted agents must have a seven day washout period prior to receiving IORT.

9.2 Participants receiving doxorubicin, T-DM1, or antibody-drug conjugates must have a fourteen day washout period prior to receiving IORT.

9.3. Participants receiving all other concurrent systemic agents will undergo consideration for a washout period prior to receiving IORT at the discretion of the study principal investigator.

Exclusion Criteria:

  1. Participants may not be pregnant or breast-feeding.
  2. Patients must not have dural lesions or leptomeningeal disease.
  3. Patients must not have psychiatric or social conditions limiting adherence to protocol guidelines.
  4. Patients must not have contraindications to anesthesia, surgery, or MR imaging with Gadolinium injection.
  5. Patients must not have a frozen section diagnosis of small cell carcinoma, lymphoma, germinoma or non-malignant histology.
  6. Patients with additional unresected brain metastases must have a limited number of lesions/or volume of intracranial disease amenable to stereotactic radiotherapy at the discretion of the study principal investigator.
  7. Patients deemed to require postoperative whole brain radiotherapy should be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shaio Woo, MD 502-562-4673 ctobcc@louisville.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04040400
Other Study ID Numbers  ICMJE 19.0619 BCC-IORT-BM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plans to share individual participant data with other researchers outside of this clinical trial's investigation team
Responsible Party Shiao Yuo Woo, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaio Woo, MD University of Louisville, JGBrown Cancer Center
PRS Account University of Louisville
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP