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New treatment option for Liver Metastases
Official title Proton Therapy in the Treatment of Liver Metastases
ClinicalTrials.gov ID: NCT01697371
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed non-lymphoma liver metastases or New radiographic liver lesions consistent with metastases in patients with known...
- 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...
- A complete history and general physical examination
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.