Expired Study
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Dallas, Texas 75390


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

STU 072010-093


NCT ID:

NCT01162278


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Texas Southwestern Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jeffrey Meyer, MD
Principal Investigator
University of Texas, Southwestern Medical Center at Dallas

Study Dates

Start Date:July 2010
Completion Date:November 25, 2017
Completion Type:Actual
Primary Completion Date:November 25, 2015
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 22, 2018
First Received Date:June 25, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases.
Time Frame:3 years
Safety Issues:False
Description:The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.
Outcome Type:Secondary Outcome
Measure:The dose-limiting toxicity.
Time Frame:3 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The actual 6 and 12 month local control rates
Time Frame:4 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:An optimal therapeutic window between control and toxicity
Time Frame:3 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The survival rate
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The 3 month tumor response rate
Time Frame:3 month
Safety Issues:False

Study Interventions

Intervention Type:Radiation
Name:SBRT
Description:Single fraction SBRT
Arm Name:single fraction
Other Name:Stereotactic Body Radiation Therapy

Study Arms

Study Arm Type:Other
Arm Name:single fraction
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Texas Southwestern Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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