Back to resultsStereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
Primary Purpose
Liver Metastases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastases focused on measuring liver metastases, Stereotactic Body Radiation Therapy
Eligibility Criteria
Inclusion Criteria:
- Signed study specific informed consent form.
- Age ≥ 18.
- Zubrod Performance Status 0-2.
- Biopsy proven primary malignancy.
- Predicted survival of >6 months.
- AJCC Stage IV disease with up to 5 liver metastases as seen on a contrast- enhanced CT, MRI or PET/CT.
- Ability to spare a critical liver volume as defined by the protocol constraints.
- Tumors must be located outside the Central Liver Zone defined by contouring the portal vein to its bifurcation + a 3-dimensional 2cm margin
Exclusion Criteria:
- Patients with a history of prior irradiation or other treatment to the liver or abdomen who after the protocol treatment would have cumulative doses to the liver or other normal tissues greater than the protocol defined constraints.
- Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, brachytherapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression. Adjuvant systemic therapy before and after the protocol therapy per section 7.0, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol as per section 8.0 is allowed.
- Germ cell or hematologic malignancies.
- History of Crohn's Disease or Ulcerative Colitis.
- Active peptic ulcer disease.
- Underlying hepatic cirrhosis with Child-Pugh class B or C
- A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process
- Men and women of reproductive potential may not participate unless they agree to use an effective contraceptive method.
- Pregnant or lactating women.
- Severe, active co-morbidity
- Abnormal labs
Sites / Locations
- The University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single fraction
Arm Description
Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 35Gy in one fraction. Subsequent cohorts of patients will receive an additional 5Gy per treatment to a maximum planned dose of 50Gy in one fraction.
Outcomes
Primary Outcome Measures
The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases.
The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.
Secondary Outcome Measures
The dose-limiting toxicity.
The actual 6 and 12 month local control rates
An optimal therapeutic window between control and toxicity
The 3 month tumor response rate
The survival rate
Full Information
NCT ID
NCT01162278
First Posted
June 25, 2010
Last Updated
August 19, 2020
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01162278
Brief Title
Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
Official Title
Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (Actual)
Primary Completion Date
November 25, 2015 (Actual)
Study Completion Date
November 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health & Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years.
Detailed Description
If the patient has met all the eligibility criteria, they will be registered to the study After successful registration to the study and treatment planning session, patients will receive a single fraction of radiation. The total dose a particular patient receives will depend on the dose cohort they are enrolled into. Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area. Although it is not mandatory, it is recommended that patients receive corticosteroid premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent) 15-60 minutes prior to each treatment for the intended purpose of modulating immediate acute inflammatory effects and providing anti-emetic support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases
Keywords
liver metastases, Stereotactic Body Radiation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single fraction
Arm Type
Other
Arm Description
Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 35Gy in one fraction. Subsequent cohorts of patients will receive an additional 5Gy per treatment to a maximum planned dose of 50Gy in one fraction.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Single fraction SBRT
Primary Outcome Measure Information:
Title
The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases.
Description
The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The dose-limiting toxicity.
Time Frame
3 years
Title
The actual 6 and 12 month local control rates
Time Frame
4 years
Title
An optimal therapeutic window between control and toxicity
Time Frame
3 years
Title
The 3 month tumor response rate
Time Frame
3 month
Title
The survival rate
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed study specific informed consent form.
Age ≥ 18.
Zubrod Performance Status 0-2.
Biopsy proven primary malignancy.
Predicted survival of >6 months.
AJCC Stage IV disease with up to 5 liver metastases as seen on a contrast- enhanced CT, MRI or PET/CT.
Ability to spare a critical liver volume as defined by the protocol constraints.
Tumors must be located outside the Central Liver Zone defined by contouring the portal vein to its bifurcation + a 3-dimensional 2cm margin
Exclusion Criteria:
Patients with a history of prior irradiation or other treatment to the liver or abdomen who after the protocol treatment would have cumulative doses to the liver or other normal tissues greater than the protocol defined constraints.
Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, brachytherapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression. Adjuvant systemic therapy before and after the protocol therapy per section 7.0, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol as per section 8.0 is allowed.
Germ cell or hematologic malignancies.
History of Crohn's Disease or Ulcerative Colitis.
Active peptic ulcer disease.
Underlying hepatic cirrhosis with Child-Pugh class B or C
A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process
Men and women of reproductive potential may not participate unless they agree to use an effective contraceptive method.
Pregnant or lactating women.
Severe, active co-morbidity
Abnormal labs
Facility Information:
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
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