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Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Metastases

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Trial Information

Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases


Inclusion Criteria:



Pathologically confirmed non-lymphoma liver metastases or

New radiographic liver lesions consistent with metastases in patients with known
pathologically confirmed non-lymphoma cancer

1-3 liver lesions measurable on CT/MRI or PET/CT performed within 6 weeks prior to study
entry

Liver metastases measuring <5cm

Life expectancy >6 months

Disease outside the liver is allowed

Age ≥ 18

ECOG Performance Scale = 0-1

Adequate bone marrow function, defined as follows:

- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 based upon CBC/differential
obtained within 4 weeks prior to registration on study

- Platelets ≥ 60,000 cell/mm3 based upon CBC/differential obtained within 4 weeks prior
to registration on study

- Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 4 weeks prior to
registration on study (Note: the use of transfusion or other intervention to achieve
Hgb ≥ 8.0 is acceptable.)

Adequate kidney function (serum creatinine <2mg/dL) based on chemistry panel obtained
within 4 weeks prior to registration on study

Adequate liver function, defined as total bilirubin <5 mg/dL, serum albumin >2.0g/dL,
serum levels of liver enzymes < 5 times the upper limit of normal, and INR < 1.5

Previous liver resection or ablative therapy is permitted

Chemotherapy and/or targeted agent therapy must be completed at least 2 weeks prior to
radiation and started at least 14 days after completion of SBPT Women of childbearing
potential and male participants must practice adequate contraception

Patient must sign study specific informed consent prior to study entry

Pretreatment evaluations required for eligibility include:

- A complete history and general physical examination

- For women of childbearing potential, a serum or urine pregnancy test must be
performed within 72 hours prior to registration

- INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to
study entry

Exclusion Criteria:

Prior invasive malignancy other than liver met primary (except non-melanomatous skin
cancer) unless disease free for > 3years

Prior radiotherapy that would results in overlap of radiation fields

Prior radiotherapy to the liver

Severe, active co-morbidity that may impact survival

CNS metastases

Tense ascites requiring frequent paracentesis

Active liver infection

Pregnancy, nursing women, or women of child bearing potential, and men who are sexually
active and not willing/able to use medically acceptable forms of contraception

Metastases location within 2cm of GI tract

-

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I of study: Number of participants with adverse events as a measure of safety and tolerability

Outcome Time Frame:

The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Safety Issue:

Yes

Principal Investigator

Gary Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

5120022

NCT ID:

NCT01697371

Start Date:

September 2012

Completion Date:

September 2017

Related Keywords:

  • Liver Metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354