Proton Therapy in the Treatment of Liver Metastases

Program Status

Recruiting

Phase

Not Applicable

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

*1-3 liver lesions measurable on CT/MRI or PET/CT performed within 6 weeks prior to study entry
*Liver metastases measuring <5cm
*Disease outside the liver is ALLOWED

Location Location Status
United States
Loma Linda University Medical Center
Loma Linda, California 92354
Recruiting

Contacts

Proton Referral Office First Call: Referral Office intake personnel
Contact
909-558-4288 or 1 800 PROTONS
Gary Yang, MD
Contact
909-558-4000 gyang@llu.edu

Inclusion Criteria

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 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 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

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

-

NCT ID

NCT01697371

Date Trial Added

2012-10-02

Updated Date

2024-05-30