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Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)

ABSTRACT: Interventions: FOLFOX +/- BV therapy L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 +/- BV:5mg/m2 XELOX +/- BV therapy L-OHP:130mg/m2 Cape:2,000mg/day +/- BV:7.5mg/m2 Primary outcome(s): response rate disease control rate Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2621954 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

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

Gunma study - Oxaliplatin-based chemotherapy and Avastin following Irinotecan-based chemotherapy with Erbitux in metastatic colorectal cancer

Project description:Interventions: first line chemotherpy FOLFIRI+Cetuximab (Cetuximab 500mg/m2/bi-week CPT-11 150mg/m2/bi-week l-LV 200mg/m2/bi-week 5-FU/bolus 400mg/m2/bi-week 5-FU/infusional 2,400mg/m2/bi-week (day 1-3)) FOLFIRI+Cetuximab second line chemotherapy (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 (day 1-3)) second line chemotherapy (2) XELOX+Bevacizumab (Bevacizumab 7.5mg/kg/tri-week L-OHP 130mg/m2/tri-week Capecitabine 2000mg/m2/day/2 (day 1-15)) Primary outcome(s): Total Progression free survival (PFS1+PFS2): PFS during first-line (PFS1) and PFS during second-line (PFS2) Study Design: Single arm Non-randomized

| 2622536 | ecrin-mdr-crc

Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer

Project description:Interventions: XELOX plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Oxaliplatin 130mg/m2 day1 Capecitabin 2,000mg/m2/day day1-15 XELIRI plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Irinotecan 200mg/m2 day1 Capecitabin 1,600mg/m2/day day1-15 Primary outcome(s): ORR; Overall response rate Study Design: Parallel Randomized

| 2622964 | 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

Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)

Project description:Interventions: 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 Primary outcome(s): Response Rate(RECIST), Duration of response Study Design: Single arm Non-randomized

| 2616344 | ecrin-mdr-crc

Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)

Project description:Interventions: XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Oxaliplatin is combined with dexamethasone (2 mg). XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Primary outcome(s): The incidence of venous pain:Grade>=2 Study Design: Parallel Randomized

| 2619736 | ecrin-mdr-crc

Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer(PF Study)

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| 2622610 | ecrin-mdr-crc

XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can’t continue continuous infusion therapy

Project description:Interventions: 1000mg/m2 of oral Xeloda twice daily on days 1 through 14 every 3 weeks. L-OHP 130mg/m2 is administered intravenous injection on day 1. (Bevacizumab 7.5mg/kg is administered intravenous injection on day 1.) Primary outcome(s): FOLFOX(+bevacizumab) from PFS Study Design: Single arm Non-randomized

| 2619416 | ecrin-mdr-crc

Early tumor shrinkage of Cetuximab and mFOLFOX6 in RAS-wild type unresectable metastatic colorectal cancer.

Project description:Interventions: Weekly Cetuximab+mFOLFOX6 Cetuximab 400mg/m2/ initial 250mg/m2/ qw Oxaliplatin 85mg/m2/ qw l-LV 200mg/m2/ qw 5FU-bols 400mg/m2/ qw 5FU-infusional 2,400mg/m2/ qw OR Biweekly Cetuximab+mFOLFOX6 Cetuximab 500mg/m2/ q2w Oxaliplatin 85mg/m2/ q2w l-LV 200mg/m2/ q2w 5FU-bols 400mg/m2/ q2w 5FU-infusional 2,400mg/m2/ q2w Primary outcome(s): ETS(Early Tumor Shrinkage) rate Study Design: Single arm Non-randomized

| 2630670 | ecrin-mdr-crc

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