Status: Closed
Activation Date: 1981MAY07
Closing Date: 1982JUN08
Phase: III
Description: Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia
Eligibility: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma TNM Stage: Tx-4, N0-1, M0 Local radiographic reading consistent with resectable disease Measurable disease and/or non-measurable disease Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio Determined to be appropriate candidate for curative-intent pancreatectomy No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy or surgery for pancreatic cancer Not pregnant and not nursing Age >/= 18 years ECOG Performance Status 0-1 Total Neuropathy Score < 2 No known Gilbert's Syndrome or known homozygosity for UGATA1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors and/or inducers of CYP3A4 is not allowed.
Objective: Primary Objective is Overall Survival. Secondary Objectives: To evaluate and compare the following in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX: " disease-free survival (DFS) " time to locoregional recurrence (TLR) " time to distant metastases (TDM " R0 resection rate " rate of unresectability, " mFOLFIRINOX dose intensity delivered and number of cycles received " adverse event profile To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the EORTC QLQ-C30 between arms. To prospectively assess the influence of diet,BMI, weight loss, physical activity, and other lifestyle habits on DFS and OD among patients with localized pancreatic cancer.
Participation: Open to member centres
Lay Description: This study is being done to answer the following question: Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after surgery?
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| HEMATOLOGIC | AL1 | 2 | 0 | 1 | 1 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| HEMATOLOGIC | AL1 | 2 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| HEMATOLOGIC | AL1 | 2 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 |