Browse
Submit Data
Databases
API
Help

Dataset Information

56 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

T-CORE1201 Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer and exploratory research of biomarker predicting effect of the treatment

ABSTRACT: Interventions: Patients who received L-OHP based chemotherapy as 1st line therapy are allocated bi-weekly cetuximab plus mFOFIRI. Patients who received CPT-11 based chemotherapy as 1st line therapy are allocated bi-weekly cetuximab plus mFOLFOX. Cetuximab is administered by 2 hours infusion before mFOLFOX or mFOFIRI. mFOLFOX: 85 mg/m2 of oxaliplatin, 200 mg/m2 of l-leucovorin, 400 mg/m2 of 5-FU by rapid intravenous (IV) infusion on day 1 and 2,400 mg/m2 of 5-FU for 46 h by continuous IV infusion as a 2-week course. mFOLFIRI: 150 mg/m2 of irinotecan, 200 mg/m2 of l-leucovorin, 400 mg/m2 of 5-FU by rapid intravenous (IV) infusion on day 1 and 2,400 mg/m2 of 5-FU for 46 h by continuous IV infusion as a 2-week course. The treatment was continued until the criteria to discontinue the trial were me Primary outcome(s): Median progression free survival (PFS) Study Design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose

DISEASE(S): Colorectal Cancer

PROVIDER: 2613819 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)

Project description:Interventions: Patients who received L-OHP based chemotherapy as 1st line therapy are allocated bi-weekly cetuximab plus mFOFIRI. Patients who received CPT-11 based chemotherapy as 1st line therapy are allocated bi-weekly cetuximab plus mFOLFOX. Cetuximab is administered by 2 hours infusion before mFOLFOX or mFOFIRI. mFOLFOX: 85 mg/m2 of oxaliplatin, 200 mg/m2 of l-leucovorin, 400 mg/m2 of 5-FU by rapid intravenous (IV) infusion on day 1 and 2,400 mg/m2 of 5-FU for 46 h by continuous IV infusion as a 2-week course. mFOLFIRI: 150 mg/m2 of irinotecan, 200 mg/m2 of l-leucovorin, 400 mg/m2 of 5-FU by rapid intravenous (IV) infusion on day 1 and 2,400 mg/m2 of 5-FU for 46 h by continuous IV infusion as a 2-week course. The treatment was continued until the criteria to discontinue the trial were met. Primary outcome(s): Median progression free survival (PFS) Study Design: Single arm Non-randomized

| 2623706 | ecrin-mdr-crc

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Project description:Interventions: A: Chemotherapy alone (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Primary resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) Primary outcome(s): Overall survival Study Design: Parallel Randomized

| 2623557 | ecrin-mdr-crc

PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.

Project description:Interventions: FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Cetuximab 1) Cetuximab : 500 mg/m2/bi-week 2) CPT-11 : 100 or 150 mg/m2/bi-week 3) l-LV : 200 mg/m2/bi-week 4) 5-FU/bolus : 400 mg/m2/bi-week 5) 5-FU/infusional : 2,400 mg/m2/bi-week (day 1-3) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2622791 | ecrin-mdr-crc

JCOG1018: Rp3 Study in Elderly Patients with MEtastatic CRC as 1st-line Tx

Project description:Interventions: Arm A: 5-FU/LV or CAP + BEV 1. 5-FU/l-LV (msDG) + BEV (1) BEV: 5 mg/kg, iv, day 1 (2) l-LV: 200 mg/m2, iv, day 1 (3) 5-FU: 2,400 mg/m2/46 hr, civ, day 1-3 2. CAP + BEV [ 50 mL/min <= Ccr ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) CAP: 1,250 mg/m2, oral, twice a day, day 1-14 [ 30 mL/min <= Ccr<50 mL/min ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) CAP: 1,000 mg/m2, oral, twice a day, day 1-14 Arm B: 5-FU/LV or CAP + L-OHP + BEV 1. mFOLFOX7 + BEV (1) BEV: 5 mg/kg, iv, day 1 (2) l-LV: 200 mg/m2 + L-OHP:85 mg/m2, iv, day 1 (3) 5-FU: 2,400 mg/m2/46 hr, civ, day 1-3 2. CAPOX + BEV [ 50 mL/min <= Ccr ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) l-LV: 130 mg/m2, iv, day 1 (3) CAP: 1,000 mg/m2,oral, twice a day, day, day 1-14 [ 30 mL/min <= Ccr < 50 mL/min ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) L-OHP: 130 mg/m2, iv, day 1 (3) CAP: 750 mg/m2, oral, twice a day, day 1-14 Primary outcome(s): Progression-free survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2614012 | ecrin-mdr-crc

Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)

Project description:Interventions: FOLFIRI + bevacizumab consisted of bevacizumab 5mg/kg as a 90-minute infusion, then, l-LV 200 mg/m2 as a 2-hour infusion, and irinotecan 150 mg/m2 given as a 90-minute infusion, followed by bolus FU 400 mg/m2 and a 46-hour infusion FU 2,400 mg/m2, repeated every 2 weeks. IRIS + bevacizumab consisted of bevacizumab 7.5mg/kg as a 90-minute infusion, then, irinotecan 150 mg/m2 given as a 90-minute infusion, followed by oral S-1 (40 mg/m2) twice daily 14 days (day 3 to 16) followed by 5 days rest, repeated every 3 weeks. Primary outcome(s): safety Study Design: Parallel Randomized

| 2616274 | ecrin-mdr-crc

JCOG2004: Randomized Phase II Study of Bevacizumab plus FOLFIRI versus Ramucirumab plus FOLFIRI versus Aflibercept plus FOLFIRI for Metastatic Colorectal Cancer after failure of First-line chemotherapy with Fluoropyrimidine and Oxaliplatin to Explore Predictive Biomarker

Project description:Interventions: Arm A: Bevacizumab+FOLFIRI (1) BEV 5 mg/kg iv (over 10 minutes) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Arm B: Ramucirumab+FOLFIRI (1) RAM 8 mg/kg iv (1hr) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Arm C: Aflibercept+FOLFIRI (1) AFL 4 mg/kg iv (1hr) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Primary outcome(s): Progression-free survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2739106 | ecrin-mdr-crc

A multicenter phase II study of FOLFIRI as first-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with homozygous for UGT1A1(FLIGHT1)

Project description:Interventions: On Day 1, patients treated with FOLFIRI therapy received a 2-hour intravenous infusion of CPT-11 (150 mg/m2) combined with 1-LV (200 mg/m2), followed by a rapid intravenous infusion of 5-FU (400 mg/m2), and then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). This regimen comprised one course of therapy and was repeated once every 2 weeks. Cycles of treatment will be continued for this study until disease progression (PD) occurs. Patients will undergo UGT1A1 genotyping before starting to receive the protocol treatment. As recommended in the US prescribing information for Camptosar;, the starting dose of CPT-11 will be reduced to 100 mg/m2 in patients who are homozygous for the *28 allelic variant of UGT1A1 (further reduced to 75 mg/m2 in such patients aged 76-80 years). No dose adjustments will be made in patients who undergo UGT1A1 genotyping after starting to receive the protocol treatment. Primary outcome(s): (1)response rate (2)incidence and severity of adverse events Study Design: Single arm Non-randomized

| 2617865 | ecrin-mdr-crc

A multicenter phaseII study of FOLFIRI as FOLFOX refractory second-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with honozygous for UGT1A1: (FLIGHT2)

Project description:Interventions: On Day 1, patients treated with FOLFIRI therapy received a 2-hour intravenous infusion of CPT-11 (150 mg/m2) combined with 1-LV (200 mg/m2), followed by a rapid intravenous infusion of 5-FU (400 mg/m2), and then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). This regimen comprised one course of therapy and was repeated once every 2 weeks. Cycles of treatment will be continued for this study until disease progression (PD) occurs. Patients will undergo UGT1A1 genotyping before starting to receive the protocol treatment. As recommended in the US prescribing information for Camptosar;, the starting dose of CPT-11 will be reduced to 100 mg/m2 in patients who are homozygous for the *28 allelic variant of UGT1A1 (further reduced to 75 mg/m2 in such patients aged 76-80 years). No dose adjustments will be made in patients who undergo UGT1A1 genotyping after starting to receive the protocol treatment. Primary outcome(s): (1) response rate (2) incidence and severity of adverse events Study Design: Single arm Non-randomized

| 2617953 | ecrin-mdr-crc

Pharmacogenomic study on colorectal cancer chemotherapy - modified FOLFOX6- (Oxaliplatin with infusional 5-FU/l-Leucovorin) and FOLFIRI (irinotecan with infusional 5-FU/l-Leucovorin)-based regimen-

Project description:Interventions: mFOLFOX6 (-BEV): On Day1, iv infusion of 85 mg/m2 of l-OHP and 175 mg/m2 of L-LV for 2hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. mFOLFOX6 (+BEV): The first treatment after the surgery is subject to the mFOLFOX6 (-BEV) regimen. From the 2nd cycle, first infusion of 5 mg/kg BEV. Then follow the mFOLFOX6 (-BEV) regimen. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. mFOLFIRI(-BEV): On Day1, iv infusion of 150 mg/m2 of CPT-11 and 175 mg/m2 of L-LV for 2 hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. mFOLFIRI (+BEV): The first treatment after the surgery is subject to the FOLFIRI (-BEV) regimen. From the 2nd cycle, first infusion of 5 mg/kg BEV. Then follow the FOLFIRI (-BEV) regimen. 1 course, 2 weeks. Continue the courses till the discontinuance criteria. Primary outcome(s): Response rate (RECISTv1.1) Study Design: Parallel Randomized

| 2622327 | ecrin-mdr-crc

A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer (JCOG1107)

Project description:Interventions: A: Open primary tumor resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m2 as a 2-hour IV on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Laparoscopic primary tumor resection followed by the same chemotherapy as arm A (mFOLFOX6 or CapeOX plus bevacizumab) Primary outcome(s): Progression-free survival Study Design: Parallel Randomized

| 2625109 | 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