Browse
Submit Data
Databases
API
Help

Dataset Information

23 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

ABSTRACT: Interventions: investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Generic name etc : LV (Levofolinate calcium) INN of investigational material : folic acid Therapeutic category code : 392 Antidotes Dosage and Administration for Investigational material : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest. Primary outcome(s): Efficacy, Safety Study Design: Open-label, Multi-center Study

DISEASE(S): Colorectal Cancer

PROVIDER: 99793 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

A phase 1/2 trial of Oxaliplatin(L-OHP) + S-1 in patients with previously untreated advanced colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Oxaliplatin | Tegafur-Gimeracil-Oteracil potassium capsule INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oxaliptatin:Infusion, Tegafur-Gimeracil-Oteracil potassium capsule:Oral Primary outcome(s): To determine RD,calculate response rate at the RD Study Design: Open-label,multicenter trial

| 99273 | ecrin-mdr-crc

Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer

Project description:Interventions: investigational material(s) Generic name etc : Irinotecan hydrochloride | Tegafur/Gimeracil/ Oteracil Potassium | Fluorouracil | Levofolinate Calcium INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Irinotecan hydrochloride : injection, Fluorouracil : injection, Levofolinate Calcium : injection, Tegafur/Gimeracil/ Oteracil Potassium capsule : oral Primary outcome(s): Progression free survival Study Design: Open label, multicenter phase 2 / 3 study

| 97751 | ecrin-mdr-crc

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Intervention name : LV (Levofolinate calcium) INN of the intervention : folic acid Dosage And administration of the intervention : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest. Primary outcome(s): Efficacy, Safety Study Design: Open-label, Multi-center Study

| 2610136 | ecrin-mdr-crc

Phase II Study of SOL and Bevacizumab Combination Therapy in patients with Untreated Metastatic Colorectal Cancer.

Project description:Interventions: investigational material(s) Generic name etc : S-1(tegafur + gimeracil + oteracil potassium)/LV/L-OHP/Bevacizumab INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium LV:folic acid OHP:oxaliplatin Bevacizumab:bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : S-1 40-60 mg bid day 1-day 7, LV 25 mg bid day 1-day 7, L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle, Bevacizumab 5 mg/kg iv. for 90 min on day 1 of each 2 weeks cycle. Primary outcome(s): Response rate(RR) RECIST Study Design: Randomized, open-label, comparative study.

| 99902 | ecrin-mdr-crc

A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

Project description:Interventions: investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Generic name etc : L-OHP (Oxaliplatin) INN of investigational material : oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Generic name etc : BV (Bevacizumab) INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks control material(s) Generic name etc : 5-FU (Fluorouracil) INN of investigational material : fluorouracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Generic name etc : l-LV (Levofolinate calcium) INN of investigational material : folic acid Therapeutic category code : 392 Antidotes Dosage and Administration for Investigational material : 200 mg IV on day 1. Repeat cycles every 2 weeks. Generic name etc : L-OHP (Oxaliplatin) INN of investigational material : oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Generic name etc : BV (Bevacizumab) INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

| 97778 | ecrin-mdr-crc

A phase II study of TSU-68 in patient with metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : TSU-68, S-1, Oxaliplatin INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. Additionally for the patients of group A, TSU-68 is orally administered at 200 mg twice a day after meals on day 1 to 21. control material(s) Generic name etc : S-1, Oxaliplatin INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. Primary outcome(s): Progression free survival RECIST (ver. 1.1) Study Design: Open-label, multicenter, randomized phase II study

| 100336 | ecrin-mdr-crc

Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Interventions: investigational material(s) Generic name etc : trifluridine/tipiracil INN of investigational material : trifluridine/tipiracil Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Generic name etc : bevacizumab INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. control material(s) Generic name etc : fluorouracil INN of investigational material : fluorouracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Generic name etc : TS-1(tegafur + gimeracil + oteracil potassium) INN of investigational material : TS-1(tegafur + gimeracil + oteracil potassium) Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : [Treatment with TS-1+ irinotecan +bevacizumab (3- Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 98099 | ecrin-mdr-crc

Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

Project description:Interventions: investigational material(s) Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin) INN of investigational material : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment. control material(s) Generic name etc : UFT(tegafur + uracil) LV (Folic acid) INN of investigational material : UFT: tegafur, uracil LV:folic acid Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment. Primary outcome(s): efficacy Disease-free survival (DFS) Study Design: Randomized, open-label, comparative study

| 97801 | ecrin-mdr-crc

A phase I study of TSU-68 in patient with metastatic colorectal cancer

| 100333 | ecrin-mdr-crc

A phase 1/2 trial of Oxaliplatin(L-OHP) + S-1 in patients with previously untreated advanced colorectal cancer

Project description:Intervention name : Oxaliplatin | Tegafur-Gimeracil-Oteracil potassium capsule Dosage And administration of the intervention : Oxaliptatin:Infusion, Tegafur-Gimeracil-Oteracil potassium capsule:Oral Primary outcome(s): To determine RD,calculate response rate at the RD Study Design: Open-label,multicenter trial

| 2609918 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

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