This trial studies how well computed tomography works in diagnosing patients with pancreatic or hepatobiliary cancer. Computed tomography may help researchers predict how patients with pancreatic or hepatobiliary cancer may respond to chemotherapy.
PRIMARY OBJECTIVES: I. To prospectively validate our pilot data that indicate that pre-therapy computed tomography-based (CT) mass transport properties correlate with overall survival. II. To prospectively validate our pilot data that indicate that local control of pancreatic and hepatobiliary tumors correlate with changes in computed tomography-based mass transport properties of the tumors after cytotoxic therapies. OUTLINE: Patients undergo CT scan at baseline and after 4 to 6 cycles of fluorouracil/irinotecan/leucovorin calcium/oxaliplatin, or after 4 infusions of gemcitabine/nab-paclitaxel (or other gemcitabine-based regimens), or 6 to 12 weeks after radiotherapy for hepatobiliary cancers. Patients may undergo optional magnetic resonance imaging (MRI) scans prior to therapy, after two weeks of therapy, and at the time of the first restaging CT scan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
259
Participants to receive 2 CT scans. One scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist.
Participant to complete the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) questionnaire at baseline visit, and follow up visit. Questionnaires should take about 10 minutes to complete.
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGCorrelation Between Local Control and Changes in Mass Transport by Computed Tomography (CT)
Local tumor progression defined by clinical signs or symptoms of local pancreatic tumor growth (e.g., worsening back/abdominal pain, obstruction, jaundice, etc.) that are documented by the attending clinician and research data coordinator and/or diagnostic imaging evidence of tumor growth. Kaplan-Meier method used to estimate probabilities of LPFS for patients with a normalized AUC ratio \<1 and patients with a normalized AUC ratio \>/=1, respectively. Log rank test applied to compare the LPFS between these two patient groups. Multivariate Cox proportional hazards models fitted to compare the LPFS between the two comparison groups, adjusting for the effects of patients' characteristics and clinical factors.
Time frame: 4 months
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