Browse
Submit Data
Databases
API
Help

Dataset Information

4 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Randomized phase II trial of Hange-shasin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer under IRIS+Bev second-line treatment

ABSTRACT: Interventions: S-1+CPT-11+bevacizumab+Placebo S-1 80-120mg/day day1-14 q4w CPT-11 100mg/m2 day1,15 q4w Bevacizumab 5mg/kg day1, 15 q4w Placebo day1-28 q4w S-1+CPT-11+bevacizumab+hange-shashin-to S-1 80-120mg/day day1-14 q4w CPT-11 100mg/m2 day1,15 q4w Bevacizumab 5mg/kg day1, 15 q4w Hange-shashin-to 7.5g/day day1-28 q4w Primary outcome(s): Incidence of grade 3 or more diarrhea until the end of 3rd cycle Study Design: Parallel Randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2627635 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Phase II study of combination chemotherapy with TS-1/irinotecan and bevacizumab as second-line therapy in patient with K-RAS mutation-type metastatic colorectal cancer

Project description:Interventions: TS-1+CPT-11+Bevacizumab TS-1 : 80,100,120mg/twice/day1-14,following two weeks off CPT-11 : 100mg/m2/biweekly Bevacizumab : 5mg/kg/biweekly Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

| 2621336 | ecrin-mdr-crc

Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer

Project description:Interventions: We use three drugs (CPT-11, TS-1, bevacizumab) for this trial. The treatment schedule of CPT-11 and bevacizumab are administrated on day 1 and day 15, and of TS-1 is administrated between day1 and day 21. The dosage of CPT-11 are 80-110/m2, and of TS-1 are 80-120mg (the dosage are calculated by body surface area), and of bevacizumab are 5 or 7mg/kg. Primary outcome(s): safety Study Design: Single arm Non-randomized

| 2616713 | ecrin-mdr-crc

A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

Project description:Interventions: arm A-1:mFOLFOX6+Bevacizumab Bevacizumab 5mg/kg/bi-week L-OHP 85mg/m2/bi-week l-LV 200mg/m2/bi-week 5-FU/bolus 400mg/m2/bi-week 5-FU/infusional 2,400mg/m2/bi-week arm A-2: CapeOX+Bevacizumab Bevacizumab 7.5mg/kg/tri-week L-OHP 130mg/m2/tri-week Capecitabine 1200-2100mg/twice/day(day 1-15) arm B-1:TS-1/CPT-11+Bevacizumab(SIRB) Bevacizumab 7.5mg/kg/tri-week CPT-11 150mg/m2/tri-week S-1 40-60mg/twice/day(day1-15)/tri-week arm B-2:TS-1/CPT-11+Bevacizumab(IRIS/BV) Bevacizumab 5mg/kg/(day1and15)/4-weeks CPT-11 100mg/m2/(day1and15)/4-weeks S-1 40-60mg/twice/day(day1-15)/4weeks Primary outcome(s): Progression free survival(PFS) Study Design: Parallel Randomized

| 2623247 | ecrin-mdr-crc

A Phase II trial of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer

Project description:Interventions: Panitumumab with irinotecan/S-1(IRIS) S-1,80-120mg/body for twice daily 14 consecutive days followed by 2 weeks rest combined with intravenous CPT-11 100mg/m^2 and P-mab 6mg/kg(weight) given on day1,15 every 4 weeks until disease progression or unmanageable toxicity. Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2623902 | ecrin-mdr-crc

The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial

Project description:Interventions: 1st line chemotheraypy: SOX+Bmab Bmab: 7.5mg/kg every 3weeks L-OHP: 130mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 2nd line chemotheraypy: SIR+Bmab Bmab: 7.5mg/kg every 3weeks CPT-11: 150mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 2nd line chemotherapy: choose either (did not use by) 1)SIR+Bmab Bmab: 7.5mg/kg every 3 weeks CPT-11: 150mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7 days off 21st 1 course. 2) SIR+Cmab Cmab: 250mg/m2 every week CPT-11: 150mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 3)SIR+Pmab Pmab: 6mg/kg every 2 weeks CPT-11: 150mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course 4)SIR CPT-11: 150mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7 days off 21st 1 course. 5)SOX+Bmab Bmab: 7.5mg/kg every 3 weeks L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7 days off 21st 1 course. 6)SOX+Cmab Cmab: 250mg/m2 every 2 weeks L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 7)SOX+Pmab Pmab: 6mg/kg every 2 weeks L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14 days on, 7days off 21st 1 course 8)SOX L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14 days on, 7days off 21st 1 course Primary outcome(s): Overall survival:OS Study Design: Parallel Randomized

| 2623112 | ecrin-mdr-crc

Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer.

Project description:Interventions: Take care of skin before the PIRIS regimen (moistureizer,sunscreen,steroid, antibiotic). Day1/Day15 panitumumab 6mg/kg irinotecan 125mg/m2 Day1~14 S-1 80-120mg/m2 q4w(until progressive disease) Primary outcome(s): Response ratte : RR Study Design: Single arm Non-randomized

| 2620021 | ecrin-mdr-crc

Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab

Project description:Interventions: S-1/irinotecan combination therapy Irinotecan 100 mg/m2(day1,15), S-1 80-120mg/day, PO from day1 to day 14 of each 28 day cycle. Primary outcome(s): Progression free survival(PFS) Study Design: Single arm Non-randomized

| 2625128 | ecrin-mdr-crc

Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer

Project description:Interventions: ETS was defined as 20% or more tumor reduction at 8 weeks. Patients with ETS after 8 weeks from the treatment start date continued FOLFIRI + Cmab as induction to 16 weeks, and switched to FOLFIRI +BV for maintenance of progressive disease. Patients without ETS at 8 weeks immediately switched to FOLFIRI+BV to control progression. FOLFIRI+Cmab induction therapy; Cetuximab: 250mg/m2day1 day1, 8(1cours day1:400mg/m2), CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2 FOLFIRI+BV maintenance therapy; Bevacizumab: 5mg/kg day1, CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2 Primary outcome(s): Progression free survival (PFS) Study Design: Single arm Non-randomized

| 2638283 | ecrin-mdr-crc

A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy

Project description:Interventions: TAS-102 plus bevacizumab combination therapy (q4w) TAS-102: 35mg/m2 BID on days 1-5 and 8-12 Bevacizumab: 5mg/kg on day1 and 15 Primary outcome(s): Progression-free survival Study Design: Single arm Non-randomized

| 2637963 | ecrin-mdr-crc

A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.

Project description:Interventions: Patients receive FOLFIRI with bevacizumab fixed 5mg/kg. (Treatment will be continued unless the disease progression, unacceptable toxicity, or consent withdrawal.) Definision of UGT1A1 polymorphisms groups: The homozygous group is patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6. The heterozygous group is patient with heterozygous genotype of either UGT1A1*28 or UGT1A1*6. The wild group is patients with no UGT1A1*28 and UGT1A1*6 mutation. CPT-11 dosage is wild and heterozygous:CPT-11 150mg/m2 homozygous:CPT-11 100mg/m2 Primary outcome(s): 1)incidence of adverse events 2)frequency of severe toxicity Study Design: Single arm Non-randomized

| 2620216 | 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