To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
HonorHealth Research Institute
Scottsdale, Arizona, United States
CA 19-9 Normalization
Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured.
Time frame: From enrollment to the end of study, up to 30 weeks.
Resectability Rate (R0)
The percentage of participants whose tumors could be completely removed by surgery after receiving study regimen with no cancer cells left at margins (R0).
Time frame: After end of treatment, from 6 months up to 2 years.
Pathologic Complete Response Rate (pCR)
Pathological complete response rate (pCR) is defined here as the absence of detectable cancer after surgical resection. Participants received a CT/MRI scan after surgical resection to monitor response using RECIST 1.1 criteria.
Time frame: After end of treatment, from 6 months up to 2 years.
Radiological Response - Complete Response (CR) or Partial Response (PR)
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; \>30% decrease in tumor size).
Time frame: From enrollment to end of study, up to 30 weeks.
Radiological Response - All Responses
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; \>30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; \>20% increase in tumor size or new lesions).
Time frame: From enrollment to the end of study, up to 30 weeks.
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combination therapy
2-Year Survival
Participants were contacted by telephone every 12 weeks to monitor survival until date of death. Participants surviving up to 2 years are reported.
Time frame: 2 years after study completion
Overall Survival
Participants were contacted by telephone every 12 weeks to monitor survival until date of death.
Time frame: Every 12 weeks from study entry, up to 32 months.
Adverse Events Related to Study Agents
The number of patients who experienced an adverse event (AE) determined to be related to one or more of the study agents. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Time frame: From enrollment to end of study, up to 30 weeks.