Proton Therapy in the Treatment of Liver Metastases
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| ClinicalTrials.gov Identifier: NCT01697371 |
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Recruitment Status :
Recruiting
First Posted : October 2, 2012
Last Update Posted : February 18, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Liver Metastases | Radiation: Proton Radiation: Proton Radiation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 35 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases |
| Study Start Date : | September 2012 |
| Estimated Primary Completion Date : | September 2026 |
| Estimated Study Completion Date : | September 2028 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Proton Radiation |
Radiation: Proton
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 Radiation: Proton Radiation |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697371
| Contact: Miriam Hernandez, RN | 909-558-4000*; 909-558-4107 ext 55240* | mvhernandez@llu.edu | |
| Contact: Gary Yang, MD | Backup: Sandi Teichman, RN | scteichm@llu.edu |
| United States, California | |
| Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Principal Investigator: Gary Yang, MD | |
| Principal Investigator: | Gary Yang, MD | gyang@llu.edu |
| Responsible Party: | Gary Yang, MD, Radiation Oncologist, MD, Loma Linda University |
| ClinicalTrials.gov Identifier: | NCT01697371 |
| Other Study ID Numbers: |
5120022 |
| First Posted: | October 2, 2012 Key Record Dates |
| Last Update Posted: | February 18, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Neoplasm Metastasis Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |