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Proton Therapy in the Treatment of Liver Metastases

Primary Purpose

Liver Metastases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton

Proton Radiation

About this trial

This is an interventional treatment trial for Liver Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Loma Linda University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Radiation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Phase II -local control within irradiated fields at 2 years

Full Information

NCT ID

NCT01697371

First Posted

September 7, 2012

Last Updated

February 20, 2023

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT01697371

Brief Title

Proton Therapy in the Treatment of Liver Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 22, 2012 (Actual)

Primary Completion Date

September 2028 (Anticipated)

Study Completion Date

September 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Local control of hepatic metastases appears to be a major determinant of overall survival. However, many patients are not suitable for resection due to medical or surgical reasons. Therefore, there is an important role for a treatment that can provide the equivalent of tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an ablative regimen of highly focused external beam radiotherapy that targets one or more discrete extracranial lesions. Published reports using SBRT to treat liver metastases have shown actuarial local control rates ranging from 50-100% with higher doses associated with better local control. In patients with metastatic liver disease, aggressive local therapy using modern radiotherapy techniques are promising and project to have a substantial role in the treatment of metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton therapy may lead to improved clinical outcomes with less morbidity, however, there is no clinical data to confirm this assertion. We thus propose a phase I study to determine the feasibility and safety of stereotactic body proton therapy in patients with liver metastases followed by a phase II study to determine the efficacy of such treatment on local control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proton Radiation

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Proton

Intervention Description

All patients will receive 3 fractions in no more than 14 days at the following levels: Level I = 12 Gy per fraction, total dose=36 Gy. Level II = 16 Gy per fraction, total dose 48 Gy. Level III = 20 Gy per fraction, total dose 60 Gy. The dose per fraction to the PTV will start at dose level I (12 Gy), but may vary from 12 Gy to 20 Gy in 3 fractions over 14 days in 4 Gy increments

Intervention Type

Radiation

Intervention Name(s)

Proton Radiation

Primary Outcome Measure Information:

Title

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

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

Secondary Outcome Measure Information:

Title

Phase II -local control within irradiated fields at 2 years

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 <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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miriam Hernandez, RN

Phone

909-558-4000*; 909-558-4107

Ext

55240*

mvhernandez@llu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gary Yang, MD

Phone

Backup: Sandi Teichman, RN

scteichm@llu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Yang, MD

Organizational Affiliation

gyang@llu.edu

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loma Linda University Medical Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gary Yang, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30788166

Citation

Kang JI, Sufficool DC, Hsueh CT, Wroe AJ, Patyal B, Reeves ME, Slater JD, Yang GY. A phase I trial of Proton stereotactic body radiation therapy for liver metastases. J Gastrointest Oncol. 2019 Feb;10(1):112-117. doi: 10.21037/jgo.2018.08.17.

Results Reference

result

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Proton Therapy in the Treatment of Liver Metastases

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