Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer

  • STATUS
    Recruiting
  • End date
    Jun 30, 2029
  • participants needed
    186
  • sponsor
    NRG Oncology
Updated on 27 September 2021

Summary

This phase III trial studies how well radiation therapy with protons works compared with photons in treating patients with liver cancer. Radiation therapy, such as photon therapy, uses high energy x-rays to send the radiation inside the body to the tumor while proton therapy uses a beam of proton particles. Proton therapy can stop shortly after penetrating through the tumor and may cause less damage to the surrounding healthy organs and result in better survival in patients with liver cancer.

Description

PRIMARY OBJECTIVES:

I. To determine if Overall Survival (OS) is different for hepatocellular carcinoma patients treated with protons compared to photons.

SECONDARY OBJECTIVES:

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).

EXPLORATORY OBJECTIVES:

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.

Details
Condition Unrectable or Locally Recurrent Hepatocellular Carcinoma
Treatment Proton Therapy (Radiation Therapy), Photon Therapy (Radiation Therapy)
Clinical Study IdentifierNCT03186898
SponsorNRG Oncology
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically (histologically or cytologically) or radiographically-proven (based on the American Association for the Study of Liver Diseases [AALSD] criteria) unresectable or locally recurrent hepatocellular cancer prior to registration
Appropriate stage for study entry based on the following diagnostic workup
All patients must have computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan prior to registration. If CT contrast is contraindicated, CT chest without contrast and magnetic resonance imaging (MRI) of abdomen is permitted
Participants must have measurable disease at study entry, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 2 cm with conventional techniques or as > 1 cm with spiral CT scan
Patients must have 3 or fewer single or multinodular tumors. For patients with a single lesion, lesion must be 15 cm or less in greatest dimension. For patients with two lesions, no lesion may be greater than 10 cm in greatest dimension. For patients with three lesions, no lesion may be greater than 6 cm in greatest dimension. Portal vein involvement or thrombosis combined with a single legion that is 1 cm and 15 cm in greatest dimension is allowed
Zubrod performance status 0-1 within 30 days prior to registration
Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry
Absolute neutrophil count (ANC) >= 1,000 cells/mm^3
Platelets >= 50,000 cells/mm^3
Hemoglobin >= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)
Total bilirubin < 4 x institutional upper limit of normal (ULN)
Transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) < 6 x institutional ULN
Albumin >= 2.5mg/dl
Creatinine < 2 mg/dl
Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable
Must have Child-Turcotte-Pugh (CTP) A or B7
The patient or a legally authorized representative must provide study-specific informed consent prior to study registration

Exclusion Criteria

PRIOR TO STEP ONE RANDOMIZATION
Definitive clinical or radiologic documentation of extrahepatic tumor, defined as extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions). Note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm
Uncontrolled prior invasive malignancy, excluding the current diagnosis
Systemic chemotherapy for the study cancer < 2 weeks prior to registration
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic
HIV positive with CD4 count < 200 cells/microliter; note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90)
Prior liver transplant
PRIOR TO STEP TWO RANDOMIZATION
Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment
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