Evaluation of combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Inoperable Advanced/recurrence Gastric Cancer Or Colorectal Cancer
PROVIDER: 2623451 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: Group A: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day. * 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day.
Group B: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day. * 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day.
Primary outcome(s): * Blood concentration of dexamethasone
Study Design: Cross-over Randomized
| 2629132 | ecrin-mdr-crc
Project description:Transcriptional analysis of sex-regulated genes from male and female dsxM-^VeGFP sexed larvae (1st instar, late 2nd /early 3rd instar and 4th instar), pupae and virgin non-blood-fed 3 day old adult A. gambiae mosquitoes
2011-05-01 | E-MEXP-3093 | biostudies-arrayexpress
Project description:Human mononuclear cells were cultured in 2 phases. In the 1st phase the culture medium contained cyclosporine A the 2nd phase contained SCF and erythropoietin. Cells were collected at 3 stages of differentiation; on day 6, 10, 12 and represented early erythroblasts, medium stage and normoblasts. Keywords: time course
2009-03-31 | GSE12407 | GEO
Project description:<p>The SUCCESS-A Study (<a href="http://www.success-studie.de">http://www.success-studie.de</a>) is a randomized Phase III study of response to treatment of early primary breast cancer with adjuvant therapy after surgical resection. The primary outcome is disease-free survival and secondary outcomes are overall survival and toxicity. The study design includes comparison of two pairs of treatment regimes performed in sequence. The first randomization contrasts treatment with and without Gemcitabine (3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy). The second randomization contrasts treatment with Zoledronate for two versus five years. Patients were recruited from 2005 to 2007 and a total of 3754 patients were included from 250 study sites across Germany. Genome-wide SNP microarray data and phenotype outcomes for the first phase of the study (treatment with and without Gemcitabine) are included in the GARNET (Genomics and Randomized Trials Network) pharmacogenomic study in this dbGaP submission. (The Zoledronate treatments are still underway).</p> <p>SUCCESS-A is a an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomization in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy, and to compare the disease free survival after randomization in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate in patients with early primary breast cancer. Patients were required to have histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>2 or histopathological grade 3, or age , ≤ 35 or negative hormone receptor, but were not allowed to have evidence of distant disease. Patients were entered into the study no later than 6 weeks after complete resection of the primary tumor. No antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment, and radiotherapy was allowed prior to study entry and during the course of the study. After surgery, leading to complete resection of the invasive and intraductal components of the primary tumor, patients were randomized to one of the following two treatments for the first phase of the project (which is included in this GARNET pharmacogenomics study):</p> <p><b>AA</b>: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day22</p> <p><b>AB</b>: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22</p> <p>A second randomization was made for assigning patients to one of the following two subsequent treatments for the second phase of the project (NOT included in the pharmacogenetic study in this dbGaP submission):</p> <p><b>BA</b>: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three years</p> <p><b>BB</b>: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years</p> <p>Patients with positive hormone receptor status (≥10% positively stained cells for estrogen and/or progesterone) of the primary tumor were recommended to receive Tamoxifen treatment 20 mg p.o. per day for 2 years, after the end of chemotherapy . Subsequent to chemotherapy, postmenopausal patients with positive hormone receptor status were recommended to be treated with Anastrozole (Arimidex®) 1 mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for those additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6 months after the completion of cytostatic treatment or with premenopausal hormone levels as defined below were recommended to receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if the following serum levels are met: LH < 20 mIE/ml, FSH < 20 mIE/ml and E2 > 20 pg/ml. Endocrine therapy will start after the end of chemotherapy.</p> <p>All patients with breast conserving therapy or more than 3 axillary lymph node metastases or in the following cases after mastectomy will receive adjuvant radiotherapy: T3/T4-carcinoma, T2-carcinoma > 3 cm, multicentric tumor growth, lymphangiosis carcinomatosa or vessel involvement, involvement of the pectoralis fascia or a safety margin < 5 mm. Radiotherapy was usually performed after the chemotherapy and parallel to the beginning of the zoledronic acid therapy.</p> <p>Initially, DNA was extracted for performing SNP microarray assays using blood collected at baseline prior to the first randomization. However, the first set of SNP microarray results indicated a quality problem with approximately 50% of the DNA samples. A majority of the problematic samples were replaced with DNA extracted from redrawn blood. The remaining problematic samples were 'restored' using an Illumina FFPE Restoration procedure. A total of 3322 subjects (1638 from arm AA and 1684 from arm AB) were successfully genotyped. Among those, 1771 were from original blood samples, 1092 from redrawn blood samples and 459 from restored blood samples.</p> <p>The SUCCESS-A study is part of the Genomics and Randomized Trials Network (GARNET, <a href="http://www.garnetstudy.org">http://www.garnetstudy.org</a>) funded by the National Human Genome Research Institute (NHGRI). The overarching goal is to identify novel genetic factors that contribute to disease-free survival for breast cancer patients using different forms of chemotherapy through large-scale genome-wide association studies of treatment response in randomized clinical trials. The study was conducted at the University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Germany. Genotyping was performed at the Johns Hopkins University Center for Inherited Disease Research (CIDR). Data cleaning and harmonization were performed at the GARNET Coordinating Center at the University of Washington.</p>
| phs000547 | dbGaP
Project description:Overall, the study aims at obtaining a comprehensive picture of the African malaria mosquito, Anopheles gambiae, transcriptome using high-coverage RNA-seq of sexed whole-insect samples collected at different developmental time points. This experiment focuses on transcriptomes of 1st, 2nd, 3rd and 4th instar male and female larvae, and 2 day old male and female adults.
2015-04-01 | E-MTAB-2527 | biostudies-arrayexpress
Project description:Interventions: Group A(Normal Group of Dexamethasone) Day1 Dexamethasone 9.9mg/body (i.v) Palonosetron 0.75mg/body Day2-3 Dexamethasone 8mg/body (p.o) This administration method repeated 4 courses.
Group B(Loss Group of Dexamethasone) Day1 Dexamethasone 9.9mg/body (i.v) Palonosetron 0.75mg/body Day2-3 Dexamethasone 2mg/body (p.o) This administration method repeated 4 courses.
Primary outcome(s): Delayed(24-120hr) complete response rate
Study Design: Parallel Randomized
| 2620971 | ecrin-mdr-crc
Project description:Intervention1: Warm foot bath therapy: In experimental arm, Warm foot bath therapy
Each session-15min.
Participants will receive warm foot bath therapy prior oxaliplatin for 15min.and post oxaliplatin for 15min.on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and in home at night once for 15min.till completion of 6cycles.
In control arm, Participants will not receive the above intervention; but only receive routine treatment.
Control Intervention1: standard routine treatment
No interventions: In experimental arm, Warm foot bath therapy Each session-15min. Participants will receive warm foot bath therapy prior oxaliplatin for 15min.and post oxaliplatin for 15min.on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and in home at night once for 15min.till completion of 6cycles. In control arm, Participants will not receive the above intervention; but only receive standard routine treatment.
Primary outcome(s): To evaluate the effects of foot bathing on peripheral neuropathy in patients receiving oxaliplatin containing chemotherapy for colorectal cancer.Timepoint: Baseline assessment- 1st day of first CT cycle using FACT-GOG NTX tool
-Assessment of CIPN on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and assessment of CIPN and associated QOL using FACT-GOG NTX tool on 1st day of 2nd and 6th chemotherapy cycle and three months after completion of 6th cycle and six months after completion of 6th cycle.
| 2603333 | ecrin-mdr-crc
Project description:The objective of the present study was to assess the gene expression profiles of canine mammary carcinoma (in unsupervised manner) classified by pathologists as the 1st, the 2nd and the 3rd grade of malignancy and compare their molecular and pathological classifications. Our analysis showed that some pathologically distinct tumours may have similar gene expression and vice-versa. Probably that is why the patients with the same pathological type of cancer often have various outcomes and respond in a heterogenous manner to anticancer agents. The molecular classification, contrary to the pathological methods, reflects the biological processes and pathways within the tumour cell, not only the morphological features. It is also helpful in the better understanding of cancer biology (genes responsible for tumourigenesis, molecular interactions within the tumour or genes involved in specific pathways which could be a target for future therapy). 18 canine mammary tumours (6 of the 1st grade of malignancy, 6 of the 2nd grade of malignancy and 6 of the 3rd grade of malignancy) were subjected to the analysis. RNA was isolated, reverse transcribed and hybridized on cDNA microarrays. Pooled RNA from all of the tumours was used as a reference, and dye-swaps were performed. Then, the unsupervised hierarchical analysis was performed.
2013-05-31 | E-GEOD-43778 | biostudies-arrayexpress
Project description:Maps of H3K27ac from normal 2nd- and 3rd-trimester cytotrophoblasts, preterm severe preeclampsia cytotrophoblasts, and 2nd-trimester amnion. Maps of H3K27me3, H3K27me3, H3K36me3, and H3K4me1 from 2nd- and 3rd-trimester cytotrophoblast. Maps of H3K9me3 from 2nd- and 3rd-trimester cytotrophoblast, smooth chorion, and basal plate. RNA-seq from 2nd- and 3rd-trimester cytotrophoblasts.
| EGAD00001006066 | EGA
Project description:Weaning male Sprague-Dawley rats were divided into 2 dietary groups to form the Zn-deficient (ZD) and Zn-sufficient (ZS) groups. After 5 weeks, the animals received intragastrically, their 1st N-nitrosomethylbenzylamine dose (NMBA, an esophagus carcinogen) at 2 mg/kg body weight. Immediately after NMBA treatment, half of the ZD rats were switched to a ZS diet to form the Zn-replenished (ZR) group, the other half of ZD rats and ZS rats continued on their respective diets. Five weeks after the 1st NMBA dose, 8 ZD, 8 ZR, and 8 ZS rats were sacrificed gene expression profiling and related studies. The remaining rats received their 2nd and 3rd NMBA dose at 6 weeks and 12 weeks after the 1st NMBA dose. At 15 weeks (endpoint) after the 1st NMBA dose, all animals were sacrificed for tumor incidence analysis and gene expression profiling studies. In this study, ZD rats documented a significantly higher tumorigenic outcome than control ZS rats (tumor incidence, ZD vs ZS: 100% vs 16.6%; tumor multiplicity, 11 ± 3.8 vs 0.5 ± 0.3, P<0.001). Replenishing zinc after the first NMBA dose led to a significantly reduced tumor incidence and multiplicity in ZR vs ZD rats (incidence, 28.9% vs 100%; multiplicity, 0.6 ± 0.4 vs 11 ± 3.8, P<0.001). Expression profiling of esophageal epithelia from NMBA-treated ZD, ZR, and control ZS rats (n=4/group) was performed at 5 weeks and at 15 weeks after the 1st carcinogen dose, using Rat Genome 230 2.0 GeneChip (Affymetrix, Santa Clara, CA)
2011-01-25 | E-MTAB-428 | biostudies-arrayexpress