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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT00841035
Eligibility Criteria:
Inclusion Criteria:
.Histologic or cytologic confirmation of pancreatic ductal adenocarcinoma.
* Pancreatic cancer must be surgically resectable: a) no evidence of distant metastasis; b) clear fat plane around the celiac and superior mesenteric arteries; c) patent portal and superior mesenteric veins
* No evidence of post-resection distant metastasis
* Pathologic confirmation of R0/R1 status following surgical resection
* Age ≥ 19 years
* Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required.
* Patient should be able to understand and offer signed written informed consent prior to study entry.
* No prior receipt of chemotherapy or radiotherapy
* Patients must demonstrate a Eastern Cooperative Oncology Group(ECOG) P.S. of 0 or 1
* End Organ function must be adequate meeting the below criteria at baseline:
White Blood Cell Count (WBC)\> 3000/mm3, absolute neutrophil count(ANC)\> 1500/mm3, Platelets\>100,000mm3 Calculated creatinine clearance \>50 ml/min, normal serum creatinine (mg/dL) (if calculated Crcl \<50 ml/min, Crcl should measured and be \> 50 ml/min) Bilirubin \<3.0 mg/dL (patients with obstructive jaundice require preoperative endoscopic biliary stenting if total bilirubin \>3.0 mg/dl) prothrombin time(PT) /partial thromboplastin time(PTT) below the upper limit of normal
Exclusion Criteria:
* Diagnosis of active (treated in past 5 years) concomitant malignancy with exception of non-melanotic skin cancer
* Transplant patients or patients receiving immunosuppression
* Presence of an underlying disease state associated with active bleeding or a past medical history of coagulopathy
* New York Heart Association Class IV congestive heart failure
* Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided
* History of non-compliance with prescribed medical care
Post-Operative Phase Inclusion
* No Evidence of Post-Resection Distant Metastasis
* Pathological confirmation of R0/R1 status following Surgical resection
* Patient must demonstrate a post-operative performance status of 0 or 1.
* End Organ function must be adequate, meeting the below criteria at baseline:
1. WBC \> 3000/mm³,ANC \> 1500/mm³, Platelets \> 100,000 mm³
2. Calculated Creatinine Clearance \> 50 ml/min,Serum Creatinine \< 1.5 mg/dl
3. Bilirubin \< 3.0 mg/dl; aspartate aminotransferase(AST) and alanine aminotransferase (ALT) \< 3 x normal value
4. PT/PTT/international normalized ratio(INR) within normal Limits.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT00841035
Study Brief:
Protocol Section:
NCT00841035