Dataset Information

Adjuvant treatment with 5-fluorouracil and folinic acid with or without irinotecan in patients with Dukes B2 or C colon cancer.

ABSTRACT: Interventions: Camptothecin-11 (CPT – 11): 80 mg/m2 in 250 ml normal saline 0,9% over a 90 min infusion followed immediately by: Folinic acid (FA): 200 mg/m2 in 500 ml normal saline 0,9% over a 120 min infusion 5-Fluorouracil (5FU): 450 mg/m2 intravenous (IV) bolus, given 60 min after initiation of FA infusion. The regimen will be administered once weekly for 4 consecutive weeks on days 1,8,15,22 followed by a 2 – week rest period. Start next cycle on day 36, for a total of 6 treatment cycles (unless intolerable toxicity occurs, which requires discontinuation of treatment). The treatment consists of 6 treatment cycles in total. Each cycle consists of 4 weeks of treatment followed by a 2-week rest period. Primary outcome(s): Disease-free survival (DFS)[3-year DFS rate (following randomisation). This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT), bone scan (if indicated), endoscopy at the end of the study] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

DISEASE(S): Colon Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2455549 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

Project description:This study was undertaken to test the hypothesis that short term exposure (4 hours) to physiologic hyperinsulinemia in normal, healthy subjects without a family history of diabetes would induce a low grade inflammatory response, independently of glycemic status. We performed euglycemic hyperinsulinemic (80 mU/m2/min) clamps in 12 healthy, insulin sensitive subjects with no family history of diabetes followed by biopsies of the vastus lateralis muscle taken basally and after 30 and 240 minutes of insulin infusion. Gene expression profiles were generated using Affymetrix HG-U133A arrays. No probe sets had significantly altered expression at 30 minutes of the insulin clamp, but 121 probe sets (117 upregulated and 4 downregulated) were significantly altered after 240 minutes. Hyperinsulinemia in normal, healthy human subjects increased the mRNAs for a number of inflammatory genes and transcription factors. Microarray and quantitative RT-PCR revealed the upregulation of chemokine, cc motif, ligand 2 (CCL2), CCL8, thrombomodulin (THBD), ras-related associated with diabetes (RRAD), metallothionein (MT), and serum/glucocorticoid regulated kinase (SGK), and downregulation of CITED2 (a CREB-binding protein-interacting transactivator), a known coactivator of PPAR-alpha. Interestingly, SGK and CITED2 are located at chromosome 6q23, where we previously detected strong linkage to hyperinsulinemia. A control saline infusion performed on 3 normal, healthy subjects without a family history of diabetes demonstrated that the genes altered following the euglycemic-hyperinsulinemic clamp were due to insulin and independent of biopsy removal. This study demonstrates that insulin acutely regulates the expression of genes involved in inflammation and transcription, and identifies several candidate genes/pathways for further investigation. Experiment Overall Design: Twelve subjects received a vastus lateralis muscle biopsy followed by a 180-min euglycemic, hyperinsulinemic (80 mU/m2.min) clamp. Muscle biopsies from each subject were homogenized in RNAStat solution (Tel-Test Inc., Friendswood, TX), using a Polytron homogenizer (Brinkmann Instruments Westbury, NY). Total RNA was purified with RNeasy and DNase I treatment (Qiagen, Chatsworth, CA). RNA was prepared for hybridization to Affymetrix (Santa Clara, CA) HG-U133A arrays according to the manufacturerâs instructions.

Dataset Information

Adjuvant treatment with 5-fluorouracil and folinic acid with or without irinotecan in patients with Dukes B2 or C colon cancer.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets