Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01162278
First received: June 25, 2010
Last updated: May 12, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Liver Metastases
Radiation: SBRT
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • The actual 6 and 12 month local control rates [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • An optimal therapeutic window between control and toxicity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • The 3 month tumor response rate [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • The survival rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single fraction
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.
Radiation: SBRT
Single fraction SBRT
Other Name: Stereotactic Body Radiation Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162278

Locations
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jeffrey Meyer, MD The University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01162278     History of Changes
Other Study ID Numbers: SCCC-02210
Study First Received: June 25, 2010
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
liver metastases
Stereotactic Body Radiation Therapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014