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Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

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ClinicalTrials.gov Identifier: NCT02880319
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Tracy Balboni, MD, Dana-Farber Cancer Institute

Brief Summary:
This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other bone

Condition or disease Intervention/treatment Phase
Bone Cancer Drug: Stereotactic Body Radiation Therapy (SBRT) Device: Stereotactic Linear Accelerator Phase 2

Detailed Description:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating metastases of the bone. "Investigational" means that the intervention is being studied.

SBRT is an advanced technique that allows for more precise delivery of radiation than with standard radiation therapy. In comparison to standard radiation therapy, it allows us to give higher doses of radiation to a tumor while limiting the radiation dose going to the surrounding normal tissues. This technology has been made possible by advances in imaging and treatment capabilities on the radiation treatment machines. SBRT works just as standard radiation therapy works by damaging cancer cells.

SBRT has been used to deliver radiation to people with cancer in the lung and those with metastases in the spine or liver. Studies of those groups have shown low rates of side effects with good rates of killing the cancer in that area and preventing it from coming back. In the current research study, the investigators are looking to further evaluate how well this type of radiation controls disease in bone and whether the toxicity (side effects) of SBRT differs from that of standard treatment. The investigators hypothesis is that toxicity might be less, as less normal tissue receives radiation with SBRT than with standard treatment. It is important to note that SBRT, just like standard radiation therapy for the participant disease, is being used to attempt to stop the growth of cancer cells in a bone metastasis and relieve or prevent any symptoms (ex. pain) associated with bone metastases. The goal of the SBRT is not to cure the participant cancer. The primary goal of the study is to see how well SBRT controls the disease in the bone, and the investigators also want to analyze its ability to control disease symptoms without added toxicity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Protocol Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oligometastatic Disease

Stereotactic Body Radiation Therapy (SBRT)to up to 3 sites of disease occurring in the bone or spine

  • Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top.
  • Dosage will be determined by physician
Drug: Stereotactic Body Radiation Therapy (SBRT)
Device: Stereotactic Linear Accelerator
Experimental: Metastatic Disease

Stereotactic Body Radiation Therapy (SBRT) to site(s) of disease occurring in the bone or spine

  • Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top.
  • Dosage will be determined by physician
Drug: Stereotactic Body Radiation Therapy (SBRT)
Device: Stereotactic Linear Accelerator



Primary Outcome Measures :
  1. Evaluate The Local Control Rate Of SBRT [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Local Progression-Free Survival [ Time Frame: 1 year ]
  2. Progression-Free Survival [ Time Frame: 1 year ]
  3. Overall Survival [ Time Frame: 1 year ]
  4. Patient Reported Quality Of Life - Acute [ Time Frame: 3 months ]
    Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.

  5. Patient Reported Quality of Life - Chronic [ Time Frame: 1 year ]
    Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Both cohorts:

    --≥18 years of age

    • ECOG performance status ≤2
    • Pathologically proven metastatic solid tumor (non-hematologic malignancy) of the bone (spine or non-spine bone)
    • Bony metastatic lesions must be ≤6 cm in maximum dimension and evaluable on either a CT or MRI scan; metastatic lesions in the spine must involve ≤3 contiguous vertebral bodies
    • No other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix
    • Ability to understand and the willingness to sign a written informed consent document
    • Surgery to the lesion in question is allowed if size criteria outlined above are met
    • Not currently pregnant or breast feeding
  • Cohort 1: Oligometastatic state

    • Oligometastatic state is defined by ≤ 3 active sites of disease, including the primary site
    • Agreement of both the Chow et al.15 and TEACHH16 models, indicating a median life expectancy of >3 months
    • Among patients with multiple sites of metastatic disease, the other sites that will not be treated on this protocol have either been previously treated or are planned for local treatment
  • Cohort 2: Re-irradiation

    • Previous radiation in the current area of disease requiring radiation
    • Life expectancy of >3 months as defined by agreement of both the Chow et al.15 and TEACHH16 models

Exclusion Criteria:

  • SBRT target size >6 cm in maximum diameter (or >100 cc in volume)
  • Hematologic malignancies (including lymphoma, multiple myeloma)
  • Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose (BED) calculation [BED (Gy2) = nd x (1+d/α/ß; where n=number of fractions, d=dose per fraction, α/ß=2)]
  • Epidural tumor <2 mm from spinal cord
  • Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed)
  • Inability to lie flat and still for treatment delivery despite anti-anxiety and/or pain medications
  • Non-English speakers are excluded from this study due to use of questionnaires which have not been validated in other languages.
  • Patients lacking the capacity to describe their symptoms are excluded as that precludes them (or anyone on their behalf) from filling out the validated questionnaires about symptoms/toxicity.
  • Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skin.

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): NCT02880319


Contacts
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Contact: Tracy Balboni, MD MPH 617-525-6687 TBalboni@partners.org
Contact: Claudia Roldan 617-582-8381 croldan@bwh.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tracy Balboni, MD MPH    617-632-3591    TBalboni@partners.org   
Principal Investigator: Tracy Balboni, MD MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Tracy Balboni, MD MPH Dana-Farber Cancer Institute

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Responsible Party: Tracy Balboni, MD, Tracy Balboni, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02880319     History of Changes
Other Study ID Numbers: 16-207
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tracy Balboni, MD, Dana-Farber Cancer Institute:
Bone Cancer

Additional relevant MeSH terms:
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Bone Neoplasms
Osteosarcoma
Bone Diseases
Neoplasms by Site
Neoplasms
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma