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A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer

ABSTRACT: Interventions: 1)Curative resection 2)UFT (Stage II) or UFT/LV (Stage III) for 1 year 1)Curative resection 2)UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year Primary outcome(s): 3 years disease free survival Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2625437 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Clinical trial to research a novel biomarker of PSK responders in patients with colorectal cancer

Project description:Interventions: 1)Curative resection 2)UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year Primary outcome(s): 3 years disease free survival Study Design: Single arm Non-randomized

| 2625436 | ecrin-mdr-crc

Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer

Project description:The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors.

| 2041766 | ecrin-mdr-crc

A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Project description:To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

| 2033414 | ecrin-mdr-crc

Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

Project description:A randomized controlled study is conducted on patients with histological stage III colorectal cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin (UFT+LV), UFT+LV / UFT, or UFT+LV+PSK / UFT+PSK. The usefulness of the three regimens was evaluated by comparing the disease-free survival rate, overall survival rate, incidence and severity of adverse event, and quality of life.

| 2020230 | ecrin-mdr-crc

A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer

Project description:Interventions: Group A (standard therapy group:UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. Group B (trial therapy group: PSK/UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 6 months. Group C (trial therapy group: PSK/UFT/LV 12M): Administration of 10 courses (12 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 12 months. Primary outcome(s): 3 year desease free survival rate Study Design: Parallel Randomized

| 2620921 | ecrin-mdr-crc

Quantitative proteomics reveals that distant recurrence-associated protein R-Ras and Transgelin predict post-surgical survival of colorectal cancer Stage III patients

Project description:Surgical resection is the major clinical intervention for Stage III colorectal cancer (CRC) currently. However, as much as 30.8% of the patients who had ever taken curative resection came out of recurrence eventually. Therefore, to facilitate formulating effective treatment plans, there is an intense demand for Stage III CRC post-surgical prognostic biomarkers. In this study, we identified total 146 differentially expressed proteins (DEPs) associated with poor prognosis in Stage III CRC patients with TMT-based quantitative mass spectrometry (MS). In these DEPs, the protein expression level of R-Ras and Transgelin were tested with immunohistochemistry (IHC) of 192 individual specimens. Further Kaplan-Meier analysis revealed that the level of R-Ras and Transgelin is associated with patients’ 5-year overall survival (OS) and disease-free survival (DFS) significantly, and multivariate Cox-regression analyses revealed that R-Ras and Transgelin are independent prognostic factors for OS and DFS respectively. In conclusion, our study presents that R-Ras and Transgelin are potential post-surgical prognostic biomarkers of Stage III CRC.

2016-06-20 | PXD002903 | Pride

Gene expression profiling of formalin fixed paraffin embedded tumor tissue identifies gastric cancer patients who are at high risk after curative surgery plus adjuvant chemoradiotherapy

Project description:Gastric cancer is the second most common cause of cancer-related death worldwide. Up to 80% of patients who undergo curative surgical resection develop locoregional or distant recurrence. A recent large-scaled meta-analysis on 3,838 patients from 17 trials has demonstrated survival benefit from adjuvant chemotherapy when compared to surgery alone. Furthermore, INT-0116 study has demonstrated a survival benefit from postoperative chemoradiation therapy with 5-fluorouracil and leucovorin in gastric cancer patients. Despite these advances, 5-year disease-free survival rates remain poor for patients diagnosed with stage III or IV gastric cancer (stage IIIA, 57.6%, stage IIIB, 39.6%; and stage IV 26.3%) underscoring the need for development of new targeted agents. On the other hand those diagnosed with stage Ib/II gastric cancer have moderate 5 year recurrence rate (76.2%) and suggest the presence of significant molecular heterogeneity with varying prognosis. We hypothesized that gene expression of profiling of formalin fixed paraffin embedded tumor (FFPET) samples using whole genome cDNA-mediated Annealing, Selection, Extension, and Ligation (WG-DASL) assay could be used to develop robust prognostic profiles for gastric cancer treated with chemoradiotherapy that are independent of clinicopathological features. We have identified and validated a gene expression signature that predicts recurrence after curative resection. We also performed pathway analyses to delineate aberrant pathways in aggressive gastric cancer which suggest targeted treatment strategies.

2014-03-01 | GSE26253 | GEO

Prediction of sensitivity of rectal cancer cells in response to preoperative chemoradiotherapy by DNA microarray analysis of gene expression profiles.

Project description:Samples were prospectively collected during colonoscopic examination from 46 rectal cancer patients before starting preoperative chemoradiotherapy. The expression profiles were determined using Affymetrix Human Genome U133 Plus 2.0 arrays. Comparison between the sample groups allow to identify a set of discriminating genes that can be used for prediction of the response to radiotherapy in rectal cancer. Specimens from 46 rectal cancer patients who approved to receive preoperative chemoradiotherapy were studied. We prospectively collected biopsy specimens during colonoscopic examination from rectal cancer before starting preoperative chemoradiotherapy. Specimens from tumors were snap-frozen in liquid nitrogen and stored at -80 C until use. Paralleled tumor specimens were formalin fixed and paraffin embedded for histologic examination and other specimens were used for RNA extraction. RNA was extracted from tumor tissue using frozen samples. The patients provided written, informed consent to the collection of specimens, and the local Ethics Committee approved the study protocol. All patients received a total dose of 50.4 Gy of radiation, UFT(300-500mg/day) and LV (75mg/day) and underwent standardized curative resection, following an interval of 4 weeks after chemoradiotherapy.

2013-01-29 | E-GEOD-35452 | biostudies-arrayexpress

Expression data from 20 human colon cancer

Project description:We obtained snap-frozen tissue samples from 20 colorectal cancer (CRC) patients with stage III disease who had undergone curative resection. The expression profiles were determined using Affymetrix Human Genome U133Plus 2.0 arrays. We used microarrays to identify potential gene deregulation correlated with the outcomes of colon cancer patients.

2014-08-26 | GSE60697 | GEO

A role of PSK-CPK28-GS2 signalling in optimizing growth and defence in tomato

Project description:Phytosulfokine (PSK) is a plant pentapeptide hormone that fulfills a wide range of functions. Although it has been frequently reported to function in the inverse regulation of growth and defence in response to (hemi)biotrophic pathogens, the mechanism involved remains largely unknown. Using tomato (Solanum lycopersicum) and Pseudomonas syringae pv. tomato (Pst) DC3000 pathogen as a system, we present compelling evidence that the tomato PSK receptor PSKR1 interacts with the calcium-dependent protein kinase CPK28, which phosphorylates the key enzyme of nitrogen assimilation glutamine synthetase GS2 at two sites (S334 and S360 sites). These post translational modifications uncouple the two PSK-induced effects on defence responses and on growth regulation, respectively. The discovery of these sites will inform breeding strategies designed to optimize the growth-defence balance. The concept that such peptide hormones can regulate plant growth and resistance in a compatible manner is attractive, not least because crop yields and fitness can be optimized simultaneously in global climate-change era.

2023-02-28 | GSE214787 | GEO

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