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Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

Primary Purpose

Bone Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Stereotactic Linear Accelerator
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Cancer focused on measuring Bone Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oligometastatic Disease

Re-irradiation to Metastatic Disease

Arm Description

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

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

Outcomes

Primary Outcome Measures

The 6-month Local Control Rate of SBRT
The 6-month local control rate is the proportion of patients free of local failure at 6 months after stereotactic body radiation therapy (SBRT). Local failure is defined as the presence of biopsy-proven recurrence or radiologic scans that demonstrate progression at the treated sites.

Secondary Outcome Measures

Number of Participants With 1-year Local Progression-Free Survival
The local progression-free survival is defined as the duration of time from registration to time of local failure or death.
Number of Participants With 2-year Progression-Free Survival
Progression-free survival is defined as the duration of time from registration to time of any progression or death.
2-year Overall Survival Rate
Overall survival is defined as the time between registration and death.
Patient Reported Quality Of Life - Acute
Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.
Patient Reported Quality of Life - Chronic
Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.

Full Information

First Posted
August 23, 2016
Last Updated
August 7, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02880319
Brief Title
Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
Official Title
Phase II Protocol Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
May 2022 (Actual)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cancer
Keywords
Bone Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oligometastatic Disease
Arm Type
Experimental
Arm Description
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
Arm Title
Re-irradiation to Metastatic Disease
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Type
Device
Intervention Name(s)
Stereotactic Linear Accelerator
Primary Outcome Measure Information:
Title
The 6-month Local Control Rate of SBRT
Description
The 6-month local control rate is the proportion of patients free of local failure at 6 months after stereotactic body radiation therapy (SBRT). Local failure is defined as the presence of biopsy-proven recurrence or radiologic scans that demonstrate progression at the treated sites.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With 1-year Local Progression-Free Survival
Description
The local progression-free survival is defined as the duration of time from registration to time of local failure or death.
Time Frame
1 year
Title
Number of Participants With 2-year Progression-Free Survival
Description
Progression-free survival is defined as the duration of time from registration to time of any progression or death.
Time Frame
2 year
Title
2-year Overall Survival Rate
Description
Overall survival is defined as the time between registration and death.
Time Frame
2 year
Title
Patient Reported Quality Of Life - Acute
Description
Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.
Time Frame
3 months
Title
Patient Reported Quality of Life - Chronic
Description
Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Balboni, MD MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

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