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

NCT01162278 | Completed Phase 1 DMC

• 1 other identifier: STU 072010-093
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases

Keywords

liver metastases; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (5)

• The dose-limiting toxicity.

  3 years

• The actual 6 and 12 month local control rates

  4 years

• An optimal therapeutic window between control and toxicity

  3 years

• The 3 month tumor response rate

  3 month

• The survival rate

  5 years

Study Arms (1)

single fraction

OTHER

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

Interventions

SBRT RADIATION

Single fraction SBRT

Also known as: Stereotactic Body Radiation Therapy

single fraction

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 14, 2010
• Study Start: July 1, 2010
• Primary Completion: November 25, 2015
• Study Completion: November 25, 2017
• Last Updated: August 20, 2020

Record last verified: 2018-01

Locations

US (1)