Browse
Submit Data
Databases
API
Help

Dataset Information

6 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)

ABSTRACT: Interventions: A: capecitabine. Patients in this group receive 8 courses of oral capecitabine, at a dose of 1,250 mg/m2 twice daily for 14 days every 21 days. B: S-1. Patients in this group receive 4 courses of oral S-1, at a dose of 40 mg/m2 twice daily for28 days every 42 days. Primary outcome(s): Disease-free survival Study Design: Parallel Randomized

DISEASE(S): Stage Iii Colorectal Cancer

PROVIDER: 2618731 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

JCOG1805: Randomized controlled study of adjuvant chemotherapy for stage II colorectal cancer patients at high risk of developing recurrence according to T-stage and three selected pathological factors

Project description:Interventions: A: Observasion (surgely-alone). Patients in this group are observed without any adjuvant chemotherapy. B: Capecitabine for 6 month: Capecitabine (1,250 mg/m2) is orally administered twice daily after meals for 14 days, followed by a 7-day rest. A total of 8 courses are administered C: CAPOX for 3 month: Oxaliplatin (130 mg/m2) is administered intravenously at day 1, and capecitabine (1,000 mg/m2) is orally administered twice daily after meals for 14 days, followed by a 7-day rest. A total of 4 courses are administered. Primary outcome(s): Relapse-free survival (RFS) Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2614308 | ecrin-mdr-crc

A Clinical trial intended to compare two formulations of Capecitabine tablets, in patients with Breast Cancer or Colorectal Cancer.

Project description:Intervention1: Capecitabine Manufactured by Mylan Pharmaceutical Inc., USA: Each patient will receive a Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose)for 14 days. The dose will be comprised of multiples of the 500 mg tablet Control Intervention1: XELODAÂ (Capecitabine 500 mg) tablets: capecitabine tablets in the doses of 2500 mg/m2/day in two divided dose i.e. in morning and evening Control Intervention2: XELODAÂ (Capecitabine 500 mg) tablets.: XELODAÂ 500 mg tablets, Manufactured by Genentech US Inc. USA).Each patient will receive a Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose)for 14 days. The dose will be comprised of multiples of the 500 mg tablet. Primary outcome(s): To characterize the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Mylan Pharmaceutical Inc., USA) relative to that of reference formulation (XELODAÂ 500 mg tablets, Manufactured by Genentech US Inc. USA) in patients of Metastatic Breast Cancer, Dukes C Colon Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label

| 2573271 | ecrin-mdr-crc

A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer

Project description:Interventions: Combination therapy of encorafenib + binimetinib+ cetuximab One cycle is 28 days. Binimetinib: 45 mg, twice daily, oral Encorafenib: 300 mg, once daily, oral Cetuximab: 400 mg/m2 for initial dose, 250 mg/m2 for subsequent doses, weekly, intravenous infusion Primary outcome(s): Confirmed objective response rate by investigators’ assessment Study Design: Single arm Non-randomized

| 2646999 | ecrin-mdr-crc

The bioequivalence study of Capecitabine in Patients with Breast or Colorectal Cancer under Fed condition

Project description:Intervention1: Capecitabine: 1250 mg/m2 oral twice a day for one day Control Intervention1: Xeloda: 1250 mg/m2 oral twice a day for two days Primary outcome(s): Pharmacokinetic parameters: Cmax and AUC0-t of capecitabine in plasma.Timepoint: 0.250, 0.500, 1.000, 1.500 Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label

| 2575050 | ecrin-mdr-crc

A multicenter randomized phase II/III trial of preoperative versus postoperative chemotherapy with XELOX plus bevacizumab in patients with resectable colorectal liver metastasis.

Project description:Interventions: A: Within 56 days after surgery, patients receive infusional oxaliplatin and oral capecitabine. Patients receive infusional bevacizumab as from second course. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. B: Patients receive infusional oxaliplatin, bevacizumab and oral capecitabine. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients do not receive bevacizumab at last course. Within 56 days after chemotherapy, patients receive surgery. Primary outcome(s): Treatment compliance (phase II) Progression-free survival (phase III) Study Design: Parallel Randomized

| 2619239 | ecrin-mdr-crc

A comparative study of Capecitabine Capsules 500 mg and Capecitabine tablet 500 mg in patients of breast, colon or rectal cancer

Project description:Intervention1: Capecitabine Extended Release Capsules 500 mg of Intas Pharmaceuticals Limited, India: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week Control Intervention1: Capecitabine film coated tablets 500 mg of Accord healthcare Inc, USA: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week Primary outcome(s): To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsors formulation- Capecitabine Extended Release Capsules 500 mg (Test drug, Intas Pharmaceuticals Ltd., India) with Capecitabine) film coated Tablets 500 mg (Reference drug, Intas Pharmaceuticals Ltd., IndiaTimepoint: Pre-dose (Day01, Day 05 to Day 07 and Day 08 Day 12 to Day 14) Post-dose on Day 07 and Day 14

| 2582199 | ecrin-mdr-crc

Pathologic Immune Pathways in Psoriasis are Rapidly Attenuated by Tofacitinib Treatment: A Randomized Phase 2 Study in Patients with Moderate to Severe Psoriasis

Project description:Here we elucidate the molecular mechanism of tofacitinib, an oral Janus kinase inhibitor, in psoriasis. Tofacitinib exhibits a multi-tiered action, with early direct effects on keratinocytes and histological and transcriptomic improvement prior to IL-17 reduction. Twelve patients with plaque psoriasis were randomized (3:1) to receive tofacitinib 10Â mg or placebo twice daily for 12 weeks. Biopsies were taken from lesional and nonâlesional skin at baseline, and from lesional skin on Day 1, Day 3, and Weeks 1, 2, 4 and 12. Biopsies were examined for psoriatic epidermal features (thickness; Ki67+ keratinocytes, keratin 16 [KRT16] mRNA expression; phosphoSTAT [pSTAT] + nuclei) and T-cell and dendritic cell (DC) subsets using immunohistochemistry. mRNA transcripts were quantified by microarray.

2016-06-30 | E-GEOD-69967 | biostudies-arrayexpress

Pathologic Immune Pathways in Psoriasis are Rapidly Attenuated by Tofacitinib Treatment: A Randomized Phase 2 Study in Patients with Moderate to Severe Psoriasis

Project description:Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. We sought to elucidate the molecular mechanisms underlying the clinical efficacy of tofacitinib in patients with psoriasis. Twelve patients with plaque psoriasis were randomized (3:1) to receive 10 mg of tofacitinib or placebo twice daily for 12 weeks. Biopsy specimens were taken from nonlesional (baseline) and lesional (baseline, days 1 and 3, and weeks 1, 2, 4, and 12) skin. Biopsy specimens were examined for psoriatic epidermal features (thickness, Ki67+ keratinocytes and keratin 16 [KRT16] mRNA expression, and phosphorylated signal transducer and activator of transcription [pSTAT]+ nuclei) and T-cell and dendritic cell (DC) subsets by using immunohistochemistry, and mRNA transcripts were quantified by using a microarray. In lesional skin keratinocyte pSTAT1 and pSTAT3 staining was increased at baseline but reduced after 1 day of tofacitinib (baseline, median of 1290 pSTAT1+ cells/?m2; day 1, median of 332 pSTAT1+ cells/?m2; and nonlesional, median of 155 pSTAT1+ cells/?m2). Epidermal thickness and KRT16 mRNA expression were significantly and progressively reduced after days 1 and 3 of tofacitinib administration, respectively (eg, KRT16 decreased 2.74-fold, day 3 vs baseline, P = .016). Decreases in DC and T-cell numbers were observed after weeks 1 and 2, respectively. At week 4, significant decreases in IL-23/TH17 pathways were observed that persisted through week 12. Improvements in clinical and histologic features were strongly associated with changes in expression of psoriasis-related genes and reduction in IL-17 gene expression. Tofacitinib has a multitiered response in patients with psoriasis: (1) rapid attenuation of keratinocyte Janus kinase/STAT signaling; (2) removal of keratinocyte-induced cytokine signaling, leading to reductions in pathologic DC and T-cell numbers to nonlesional levels; and (3) inhibition of the IL-23/TH17 pathway.

2016-06-30 | GSE69967 | GEO

Gene expression of primary breast cancers from patients before and after neo-adjuvant Tamoxifen treatment

Project description:Tumor gene expression data (microarray from FFPE) was obtained from breast cancer patients enrolled in a pre-operative window trial (ClinicalTrials.gov Identifier: NCT00738777). Patients received an oral loading dose of 40 mg of tamoxifen twice daily for the first seven days, followed by a daily dose of 20 mg until surgery. A core needle biopsy of the tumor was taken prior to treatment (n=62) and post-treatment tumor material (n=40) was obtained during surgery 20.7 (±9.6) days later. Paired material was available for 27/74 patients. Differential analysis comparing gene expression before and after Tamoxifen treatment implicated activation of the NFκB pathway and an enrichment of EMT/stemness features upon Tamoxifen treatment. In line with these findings, exposure of ER+ breast cancer cell lines to tamoxifen, in vitro and in vivo, gives rise to a tamoxifen-tolerant population with similar NFκB activity and EMT/stemness characteristics as described in the corresponding publication.

2020-04-06 | GSE147271 | GEO

JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer

Project description:Interventions: A: FTD/TPI monotherapy FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 and 8-12 in a 28-day cycle) B: Bi-weekly FTD/TPI+BEV combination Bi-weekly FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 in a 14-day cycle) with BEV (5 mg/kg on day1, every 2 weeks) Primary outcome(s): Overall survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2614546 | ecrin-mdr-crc

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