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

June 25, 2010
May 12, 2014
July 2010
July 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01162278 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Metastases
Radiation: SBRT
Single fraction SBRT
Other Name: Stereotactic Body Radiation Therapy
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.
Intervention: Radiation: SBRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2018
July 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01162278
SCCC-02210
Yes
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Jeffrey Meyer, MD The University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP