Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
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|ClinicalTrials.gov Identifier: NCT03186898|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unrectable or Locally Recurrent Hepatocellular Carcinoma||Radiation: Proton Therapy (Radiation Therapy) Radiation: Photon Therapy (Radiation Therapy)||Not Applicable|
I. To determine if Overall Survival (OS) is different for hepatocellular carcinoma patients treated with protons compared to photons.
I. To determine the difference in Progression-Free Survival (PFS) in patients with hepatocellular carcinoma (HCC) treated with protons compared to patients with HCC treated with photons.
II. To determine the difference in local progression (LP) in patients with HCC treated with protons compared to patients with HCC treated with photons.
III. To determine differences in toxicity in patients with HCC treated with protons versus photons.
IV. To determine differences in fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue in patients with HCC treated with protons, versus photons; as well as quality-adjusted survival, if the primary endpoint is met.
V. To determine if there are correlations between the baseline values of HGF and outcomes (OS/PFS/fatigue).
I. To determine differences in overall Quality of Life, measured by FACT-Hep in patients with HCC treated with protons.
II. Biospecimen collection for future correlative science projects.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo proton therapy over 15-24 days for 5 or 15 fractions.
ARM II: Patients undergo photon therapy over 15-24 days for 5 or 15 fractions.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma|
|Actual Study Start Date :||June 22, 2017|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||August 31, 2027|
Experimental: Proton Therapy (Radiation Therapy)
Patients undergo proton therapy over 15-24 days for 5 or 15 fractions.
Radiation: Proton Therapy (Radiation Therapy)
Undergo proton therapy
Experimental: Photon Therapy (Radiation Therapy)
Patients undergo photon therapy over 15-24 days for 5 or 15 fractions.
Radiation: Photon Therapy (Radiation Therapy)
Undergo photon therapy
- Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. This analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years. ]OS will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with OS.
- Progression-Free Survival (PFS) [ Time Frame: From the date of randomization to the date of first PFS failure or last follow-up for patients without a reported PFS event assessed up to 5 years. ]PFS is defined as local/regional/distant progression or death due to any cause and will be estimated by the Kaplan-Meier method. The distributions of PFS between treatment arms will be compared using the log rank test.
- Local Progression (LP) [ Time Frame: From the date of randomization to the date of first LP or date of last follow-up for patients without an LP event reported assessed up to 5 years. ]LP will be estimated by the cumulative incidence method and compared using Gray's test. The Fine-Gray regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with LP.
- Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 [ Time Frame: From baseline up to 5 years ]A Chi-square test will be used to compare the number of patients with at least 1 grade 3 or higher adverse events between the treatment arms.
- Fatigue as measured by the PROMIS fatigue short form version 1.0 8a [ Time Frame: From baseline to the assessment at 1 month post treatment completion. ]Change in fatigue will be compared between treatment arms using a t-test. If the data do not satisfy the normality assumption, a Wilcoxin test may be used instead.
- Correlation of Hepatocyte Growth Factor (HGF) biomarker with OS, PFS and fatigue [ Time Frame: This analysis occurs after the primary endpoint has been reported; estimated to occur around 5 years. ]HGF will be dichotomized at 2311 pg/mL and evaluated for prognostic significance using Cox regression model.
- Quality Adjusted Survival (if primary endpoint is met) [ Time Frame: This analysis occurs after the primary endpoint has been reported; estimated to occur around 5 years. ]The EuroQol (EQ-5D) will be used to assess quality-adjusted survival.
- Exploratory - Overall Quality of Life (QOL) [ Time Frame: From baseline to the assessment at 6 months post treatment completion ]QOL will be measured by the FACT-Hep v 4. An improvement in the FACT-HEP, defined as an increase of 5 points, will be assessed.
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): NCT03186898
|United States, Illinois|
|Northwestern Medicine Cancer Center Warrenville||Recruiting|
|Warrenville, Illinois, United States, 60555|
|Contact: Nasiruddin Mohammed 630-315-1918 Claudine.Gamster@CadenceHealth.org|
|Principal Investigator: Nasiruddin Mohammed|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Theodore S. Hong 877-726-5130|
|Principal Investigator: Theodore S. Hong|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Hyun Kim 800-600-3606 email@example.com|
|Principal Investigator: Hyun Kim|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Eugene J. Koay 713-792-3245|
|Principal Investigator: Eugene J. Koay|
|Principal Investigator:||Theodore Hong||NRG Oncology|