Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT01523457
Eligibility Criteria:
Inclusion Criteria:
* Pathologic or cytologic documentation of pancreatic adenocarcinoma
* Metastatic or locally advanced unresectable disease, including borderline unresectable disease
* Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
* Measurable or non-measurable assessable disease
* No prior treatment (chemotherapy, biological therapy, or radiotherapy) for metastatic or non-metastatic locally advanced unresectable pancreatic cancer
* 6 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for resected pancreatic cancer
* No prior treatment with oxaliplatin or irinotecan
* No prior treatment with fluoruouracil or capecitabine unless administered as a radiosensitizing drug during adjuvant/neoadjuvant chemoradiotherapy after/before resection of pancreatic cancer
* Patients who received chemotherapy \> 2 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed \> 2 years ago and there is no evidence of the second malignancy at the time of study entry
* \> 4 weeks since major surgery
* No other concurrent anticancer therapy
* ECOG Performance Status: 0-1
* Age \> 18
* No other malignancy within past two years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
* Paraffin block or slides must be available
* Adequate organ function
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No \> grade 1 sensory peripheral neuropathy
* No uncontrolled seizure disorder, active neurological disease, or known CNS disease
* No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
* No history of chronic diarrhea
* Not pregnant and not nursing
* No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
* Laboratory parameters as follows: absolute neutrophil count ≥ 1,500/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9 g,/dL, creatinine \< 1.5 X ULN or estimated GFR \> 30 ml/min, bilirubin \< 1.5 X ULN, AST and ALT \< 3 X ULN, negative pregnancy test in women of childbearing age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01523457
Study Brief:
Protocol Section:
NCT01523457