EPOCH Clinical
Trial Information

Protocol TS-102 / NCT01483027

An international Phase III clinical trial evaluating yttrium-90 trans-arterial radioembolization (TheraSphere®) in patients with metastatic colorectal carcinoma (mCRC) of the liver who have failed first-line chemotherapy

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An open-label, prospective, multicenter, randomized, Phase III clinical trial evaluating yttrium-90 transarterial radioembolization with TheraSphere® in patients with metastatic colorectal carcinoma (mCRC) of the liver who have failed first-line chemotherapy.25,26

RANDOMIZE TREATMENT GROUP
TheraSphere® plus standard-of-care chemotherapy: oxaliplatin- or irinotecan-based

CONTROL GROUP
Standard-of-care chemotherapy: oxaliplatin- or irinotecan-based

ENDPOINTS
Primary: Progression-free survival (per RECIST v1.1)
Secondary: Safety, Overall survival, tumor response, time to symptomatic progression, hepatic progression-free survival, quality of life (FACT-C)

Objective
  • To evaluate the efficacy and safety of TheraSphere® in patients with mCRC of the liver scheduled to receive second-line chemotherapy.

Primary Endpoint
  • Progression-free survival (PFS) according to RECIST criteria v1.1 from time of randomization

Secondary Endpoints
  • Overall survival (calculated from randomization to death)
  • Hepatic PFS (time from randomization to date of disease progression in the liver according to RECIST v1.1, or death)
  • Time to symptomatic progression (from time of randomization to assessment of ECOG performance status >2 deterioration in performance status is to be confirmed at one subsequent evaluation 8 weeks later)
  • Disease control rate (per RECIST v1.1)
  • Quality of life (Functional Assessment of Cancer Therapy; FACT-C)
  • Adverse events (CTCAE v4.0)

Inclusion Criteria
  • Patients 18 years of age or older, male or female, of any ethnic or racial group
  • If primary tumor has not been resected, it must be stable
  • Patients with unresectable metastatic colorectal cancer of the liver (unresectable unilobar or bilobar disease) who have disease progression with first-line chemotherapy (either oxaliplatin- or irinotecan-based regimen)
  • Patients eligible for second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
  • Must have baseline efficacy images with measurable target tumors in the liver according to RECIST v1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy
  • Tumor replacement ≤50% of total liver volume
  • ECOG status 0-1 through screening to first treatment on study
  • Will have completed the first line chemotherapy regimen at least 14 days prior to the initiation of second-line chemotherapy under the protocol
  • Patient is willing to participate in the study and has signed the study informed consent
  • Serum creatinine ≤2.0 mg/dL; serum bilirubin up to 1.2 x upper limit of normal; albumin ≥3.0 g/dL; neutrophil count >1200/mm3 (1.2 x 109/L)

Exclusion Criteria
  • History of hepatic encephalopathy
  • Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (e.g., closure device)
  • History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
  • Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
  • Cirrhosis or portal hypertension
  • Prior external beam radiation treatment to the liver
  • Prior intraarterial liver-directed therapy, including transarterial chemoembolization or 90Y microsphere therapy
  • Planned liver-directed therapy or radiation therapy
  • Biological agents within 28 days prior to receiving TheraSphere®
  • Intervention for, or compromise of, the Ampulla of Vater
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient
  • Patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be HIV-positive or have acute HBV or HCV
  • Confirmed extrahepatic metastases. Limited indeterminate lesions in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion <1 cm any number of lymph nodes with each individual lesion <1.5 cm)
  • Contraindications to the planned second-line standard-of-care chemotherapy regimen
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding
  • Participation in a clinical trial with an investigational therapy within 30 days prior to randomization
  • Comorbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere® treatment, in the Investigator's judgment