Browse
Submit Data
Databases
API
Help

Dataset Information

6 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer

ABSTRACT: Interventions: Group A:mFOLFOX6 Day 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ------------- | 5-FU 400mg/m2 iv Rapid Group B:TS-1/CPT-11 CPT-11 80 mg/m2CPT-11 80 mg/m2 1.5 hours 1.5 hours TS-1 40-60 mg/m2 | | | | Day 1 day 15 day 21 day 35 One course takes 35 days (5 weeks). Primary outcome(s): Response Rate(RECIST) Study Design: Parallel Randomized

DISEASE(S): Patients With Advanced And/or Recurrent Colorectal Cancer

PROVIDER: 2616289 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

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

Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.

Project description:Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 3 consecutive weeks every 5 weeks. Primary outcome(s): response rate Study Design: Single arm Non-randomized

| 2622561 | 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

Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer

Project description:Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks. Bevacizumab 7mg/kg is administered with 30-90 min intravenous injection on days 1, 15. Primary outcome(s): Overall response rate Study Design: Single arm Non-randomized

| 2622491 | ecrin-mdr-crc

A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin

Project description:Interventions: TAS-102 25-35 (mg/m2) day1-5 CPT-11 150-180 (mg/m2) day 1 Bevacizumab 5 (mg/kg) day 1 every 2 weeks Primary outcome(s): Part1(dose-escalation): DLT between first 2 cycles Part2(expansion): the incidence of febrile neutropenia Study Design: Single arm Non-randomized

| 2635113 | 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

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

Project description: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

| 2627635 | ecrin-mdr-crc

Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type

Project description:Interventions: FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Erbitux Cetuximab 400 mg/m2(day1) Cetuximab 250 mg/m2/week, (except day 1) CPT-11 100 or 150 mg/m2/bi-week l-LV 200 mg/m2/bi-week 5-FU/bolus 400 mg/m2/bi-week 5-FU/infusional2,400 mg/m2/bi-week (day 1-3) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2617576 | ecrin-mdr-crc

Phase1 trial of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer

Project description:Interventions: Panitumumab:Bi-weekly administration 6 mg/kg TS-1 is orally administered b.i.d. on days 1-14 and CPT-11 is intravenously administered on days 1,8 every 4 weeks S-1:Level1 65mg/m2 day1-14 Level2 80mg/m2 day1-14 CPT-11:Level1,2 125mg/m2, day1 Primary outcome(s): Maximum tolerated dose Recommended dose Study Design: Single arm Non-randomized

| 2620191 | ecrin-mdr-crc

A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type

Project description:Interventions: Panitumumab;tri-weekly administration 9mg/kg. and CPT-11 is administered as an intravenous infusion at a dose of 150mg/m2(or 125 mg/m2)on day 1 and TS-1 is orally administered on days 1-14 of a 21-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): phase1 recommend dose of 1st cycle phase2 response rate Study Design: Single arm Non-randomized

| 2620657 | 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