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

Status
Active
Cancer Type
Liver Cancer / Hepatoblastoma
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03186898
Protocol IDs
NRG-GI003 (primary)
NRG-GI003
NCI-2016-02009
NRG-GI003
Study Sponsor
NRG Oncology

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.

Objectives

PRIMARY OBJECTIVE:
I. To determine if protons improve overall survival (OS) of hepatocellular carcinoma 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 hepatocyte growth factor (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 up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 5 years.

Eligibility

  1. 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
  2. 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 * Patient 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 lesion that is >= 1 cm and =< 15 cm in greatest dimension is allowed
  3. Zubrod performance status 0-1 within 30 days prior to registration
  4. Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry
  5. Absolute neutrophil count (ANC) >= 1,000 cells/mm^3
  6. Platelets >= 50,000 cells/mm^3
  7. Hemoglobin >= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)
  8. Total bilirubin < 4 x institutional upper limit of normal (ULN)
  9. Transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) < 6 x institutional ULN
  10. Albumin >= 2.5 g/dl
  11. Creatinine < 2 mg/dl
  12. Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable
  13. Must have Child-Turcotte-Pugh (CTP) A or B7
  14. The patient or a legally authorized representative must provide study-specific informed consent prior to study registration
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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