Browse
Submit Data
Databases
API
Help

Dataset Information

7 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRCOpen, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatment for patients with undetectable EGFR-status in metastatic colorectal cancer.

ABSTRACT: Primary objectives: To assess the rate of best confirmed response of 5-FU/FA plus oxaliplatin plus cetuximab as first-line treatment for undetectable epidermal growth factor in metastatic colorectal cancer. Primary endpoints: The primary target variable related to efficacy is the best overall confirmed tumor response to therapy of either CR or PR . Secondary target variables related to efficacy comprise variables based on tumor response and survival time. The following variables describe those, which are directly related to tumor response: • The duration of response to assess the time from first assessment of CR or PR until the first date of PD or death• Disease control on therapy, i.e. best overall response is either CR, PR, SD, provided the confirmation criteria are met (see section 7.2.3) • Progression-free survival time of a patient being defined as the time in months from start of treatment until PD is observed or death occurs due to any cause within 90 days after the last tumor assessment. In addition, survival time and curative metastatic surgery will be of further interest.

DISEASE(S): Metastasized Colorectal Cancer,Colorectal Cancer Metastatic

PROVIDER: 2518616 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

MicroRNA signature predict chemotherapy response in patients with advanced colorectal cancer

Project description:The aim of our study was to evaluate the ability of miRNA expression patterns to predict chemotherapy response in a cohort of 39 patients with metastatic colorectal carcinoma To define miRNA signature, samples were obtained from tumor tissue samples of 39 patients . Patients were divided into responders or non-responders according to tresponse treatment with a chemotherapy regimen that included fluoropyrimidines and either oxaliplatin or irinotecan .Tumor response was evaluated by conventional methods according to the standard RECIST 1.0 criteria: a complete response (CR) was defined as the disappearance of all measurable and evaluable evidence of disease; a partial response (PR) was defined as a > 30% decrease in the sum of the longest diameters of target lesions; stable disease (SD) was considered if the tumor burden decreased less than 30% or increased less than 20%; and progressive disease (PD) was indicated by a >20% increase in the sum of the longest diameters of target lesions or the appearance of any new lesion. Patients were classified according to best response to chemotherapy in two groups: those that achieved an objective response (Responders [R]: CR + PR) and those that did not (Non-responders [NR]: SD + PD). Mature human miRNA expression was detected and quantified using the TaqMan® Low Density Arrays (TLDA). The Human MicroRNA Card Set v2.0 array is a two card set containing a total of 384 TaqMan® MicroRNA Assays per card to enable accurate quantification of 667 human microRNAs, all catalogued in the miRBase database. Expression of target miRNAs was normalized in relation to the expression of MammU6. Cycle threshold (Ct) values were calculated using the SDS software v.2.3 using automatic baseline settings and a threshold of 0.2. Relative quantification of miRNA expression was calculated by the 2−ΔCt method (Applied Biosystems user bulletin no. 2 (P/N 4303859)).

2014-08-12 | E-GEOD-48664 | biostudies-arrayexpress

Trancription profling of In-transit extremity melanoma II lesions

Project description:An evaluation of biopsies from patients with in-transit extremity melanoma who have been treated with melphalan in the setting of isolated limb infusion Gene expression profiles were obtained from 52 lesions across 28 patients and evaluated for expression values that correlated with response to melphalan isolated limb infusion Chemotherapy response analysis: complete response - CR; partial response - PR; stable disease - SD; progressive disease - PD. 52 samples.

2010-03-09 | E-GEOD-19293 | biostudies-arrayexpress

Lung cancer metabolomics analysis

Project description:This study explored models predictive of staging and chemotherapy response based on metabolomic analysis of fresh, patient-derived non-small cell lung cancer (NSCLC) core biopsies. Prospectively collected tissue samples before initial treatment were evaluated with high-resolution 2DLC-MS/MS and 13C-glucose enrichment, and the data were comprehensively analyzed with machine learning techniques. Patients were categorized as Disease-Control (DC) [encompassing complete-response (CR), partial-response (PR), and stable-disease (SD)] and Progressive-Disease (PD). Four major types of learning methods (partial least squares discriminant analysis (PLS-DA), support vector machines (SVM), artificial neural networks, and random forests) were applied to differentiate between positive (DC and CR/PR) and poor (PD and SD/PD) responses, and between stage I/II/III and stage IV disease. Models were trained with forward feature selection based on variable importance and tested on validation subsets.

2020-09-16 | ST001527 | MetabolomicsWorkbench

In-transit extremity melanoma III

Project description:An evaluation of biopsies from patients with in-transit extremity melanoma who have been treated with melphalan in the setting of isolated limb infusion or isolated limb perfusion. Gene expression profiles were obtained from 21 lesions across 19 patients and evaluated for expression that correlated with response to melphalan isolated limb infusion. Chemotherapy response analysis: complete response - CR; partial response - PR; stable disease - SD; progressive disease - PD; not evaluable - n.e.

2011-12-22 | E-GEOD-34599 | biostudies-arrayexpress

Efficacy and Safety of T Cell Receptor Modified T (TCR-T) Cells in Advanced Pancreatic Cancer, Lung Cancer and Colorectal Cancer Therapy

Project description:Interventions: experimental group:TCR-T treatment Primary outcome(s): complete response (CR);partial response (PR);stable disease (SD);progressive disease (PD);objective response rate (ORR);duration of response (DOR);tumor marker (TM);dose limited toxicity (DLT);markers of infection Study Design: Single arm

| 37438 | ecrin-mdr-crc

Phase II Study with Symadex (C-1311) in Patients with Metastatic Colorectal Cancer after Oxaliplatin and/or Irinotecan Failure

Project description:Primary objectives: Evaluate the overall response rate (CR+PR) using RECIST criteria. Primary: Overall response rate (ORR) = complete response (CR) + partial response (PR) using RECIST criteria. Secondary: Time to progression (TTP) and duration of response.

| 2518286 | ecrin-mdr-crc

A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination with AMG 479 in Subjects with Advanced, Refractory Solid Tumors.--------------------------------------------------------Estudio abierto de fase 1b/2 con escalada de dosis de AMG 655 en combinación con AMG 479 en sujetos con tumores sólidos refractarios y avanzados.

Project description:Primary objectives: Part 1: To identify a dose of AMG 655 in combination with AMG 479 that is safe andtolerated as determined by the incidence of dose limiting toxicity (DLT).Part 2: To estimate the efficacy, as measured by the objective response rate (ORR;confirmed complete response [CR] and partial response [PR] using modified Response Evaluation Criteria in Solid Tumors [RECIST]) of AMG 655 in combination with AMG 479. Primary endpoints: Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as DLTPart 2: ORR (confirmed CR and PR, by modified RECIST)

| 2525060 | ecrin-mdr-crc

Effect of intestinal microbiome diversity on the efficacy and survival of chemotherapy for advanced non-small cell lung cancer

Project description:Interventions: Response Group:none;None Response Group:Nil Primary outcome(s): CR;PR;SD;PD;PFS;OS;Gut microbiome;Fecal metabolomics;Immune factor Study Design: Factorial

| 2689133 | ecrin-mdr-crc

Effects of Sex, Strain, and Energy Intake on Hallmarks of Aging in Mice

Project description:Calorie restriction (CR) is the most robust non-genetic intervention to universally delay the onset of age-related diseases and extend mean and maximum lifespan. However, species, strain, sex, diet, age of onset, and level of CR are emerging as important variables to consider for a successful CR response. Here, we investigated the role of strain, sex and level of CR on outcomes of health and survival in mice. Response to CR varied from lifespan extension to no effect on survival, while consistently delaying the onset and impact of diseases independently of strain, sex and level of dietary restriction. CR led to transcriptional and metabolomics changes in the liver indicating anaplerotic filling of the Krebs cycle together with fatty acid fueling of mitochondria. Additionally, CR prevented the age-associated decline in the proteostasis network. Further, CR increased mitochondrial number and preserved their ultrastructure and function with age. Abrogation of mitochondrial function by deletion of fumarate hydratase or malate dehydrogenase 2 negated the life-prolonging effects of CR in yeast and worms. In F1 hybrid strains of mice, the lifespan response to CR tracked with the dam, indicating that the mitochondrial haplotype is an important regulator of CR. Our data illustrate the complexity of the CR responses within a single animal species in the context of aging, with a clear separation of outcomes related to health and survival, highlighting the complexities of translation of CR into human interventions. The study examines the effects of sex (male/female), mouse strain (DBA2/J versus C57BL/J), and diet (Ad libitum, 20% caloric restriction (20%CR), or 40%CR) using six biological replicate samples per group.

2016-06-27 | E-GEOD-81959 | biostudies-arrayexpress

Phase II trial melphalan ILI plus ADH-1 for treatment of in-transit extremity melanoma

Project description:An evaluation of biopsies from patients with in-transit extremity melanoma who have been treated with ADH-1 followed by melphalan in the setting of isolated limb infusion Gene expression profiles were obtained from 28 lesions across 15 patients and evaluated for expression values that correlated with ADH-1 treatment given 4-8hrs prior to melphalan isolated limb infusion Chemotherapy response analysis: complete response - CR; partial response - PR; stable disease - SD; progressive disease - PD; lost to follow-up - LTU/F ADH-1 treatment classification: 'pre' - lesions obtained prior to any treatment with ADH-1; 'post' - lesions obtained just prior to ILI with melphalan after 1 treatment with ADH-1; '2nd' - lesions obtained after a 2nd dose of ADH-1 given 8 days after melphalan ILI

2011-01-01 | E-GEOD-22968 | biostudies-arrayexpress

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data