Proton Therapy in the Treatment of Liver Metastases
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|ClinicalTrials.gov Identifier: NCT01697371|
Recruitment Status : Recruiting
First Posted : October 2, 2012
Last Update Posted : October 25, 2017
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2022|
|Estimated Study Completion Date :||September 2022|
|Experimental: Proton Radiation||
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 ]
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: Bernadette Bautista, RN||800-496-4966; 909-558-4000 ext firstname.lastname@example.org|
|Contact: Gary Yang, MD||Backup: Sandi Teichman, RNemail@example.com|
|United States, California|
|Loma Linda University Medical Center||Recruiting|
|Loma Linda, California, United States, 92354|
|Principal Investigator: Gary Yang, MD|
|Principal Investigator:||Gary Yang, MDfirstname.lastname@example.org|