Browse
Submit Data
Databases
API
Help

Dataset Information

8 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer

ABSTRACT: Interventions: Surgical hepatectomy followed by chemotherapy (mFOLFOX6) 12cycles. mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly) Pre-operative chemotherapy(mFOLFOX6 plus cetuximab) 6cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6 plus cetuximab) 6cycles. Cetuximab(loading dose 400mg/m2, 250 mg/m2/week), mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly) Primary outcome(s): Progression free survival Study Design: Parallel Randomized

DISEASE(S): Resectable Colorectal Liver Metastases

PROVIDER: 2623200 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Project description:Interventions: mFOLFOX6+cetuximab Cetuximab loading dose 400mg/sqm,250 mgsqm/week L-OHP 85 mg/sqm/biweekly Levofolinate 200 mg/sqm/biweekly 5-FU bolus 400 mg/sqm/biweekly 5-FU continuous 2,400 mg/sqm/biweekly Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

| 2619647 | ecrin-mdr-crc

Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer

Project description:Interventions: cetuximab loading dose 400mg/m2, 250mg/m2/week L-OHP 85mg/m2/biweekly levofololinate 200mg/m2/biweekly 5-FU bolus 400 mg/m2/biweekly 5-FU continuous 2,400 mgm2/biweekly / cetuximab loding dose 400 mg/m2, 250 mg/m2/week L-OHP 75-130 mg/m2/tri-weekly S-1 80-120 mg/day, day1-14 Primary outcome(s): Correlation between the reported biomarkers (EGFR expression, ligand expression to EGFR, BRAF, PI3K, and PTEN expression) or new ones (DNA microarray, analysis of microRNA expression, and DNA SNP analysis) and the response to cetuximab containing combination therapies Study Design: Parallel Randomized

| 2626017 | 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

A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

Project description:Interventions: Pre-operative chemotherapy(mFOLFOX6) 4cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6) 8cycles, mFOLFOX6(L-OHP85mg/m2, Levofolinate200mg/m2, 5-FU/bolus400mg/m2, 5-FU/continuous2,400mg/m2 every 2 weeks) Primary outcome(s): Liver resection rate Study Design: Single arm Non-randomized

| 2625119 | 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

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

study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer

Project description:Interventions: CXCR4-CEC>=20 mFOLFOX6,Bevacizumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Bevacizumab:5mg/m2 CXCR4-CEC>=20 mFOLFOX6,Panitumumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Panitumumab :6mg/m2 CXCR4-CEC<20 mFOLFOX6,Bevacizumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Bevacizumab:5mg/m2 CXCR4-CEC<20 mFOLFOX6,Panitumumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Panitumumab :6mg/m2 Primary outcome(s): Progression-free survival Study Design: Parallel Randomized

| 2623948 | 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

Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer

Project description:Interventions: Intravenous administration of l-Leucovorin 175 mg/body, Oxaliplatin 85 mg/m2 as a 2-hour infusion followed by bolus 5-FU 400 mg/m2 and 46hr infusion 5-FU 2,400 mg/m2 every two weeks Primary outcome(s): Response rate(best tumor shrinkage(rate)) Study Design: Single arm Non-randomized

| 2609819 | ecrin-mdr-crc

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

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