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Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (PARADIGM study)

ABSTRACT: Interventions: investigational material(s) Generic name etc : mFOLFOX6 + panitumumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks control material(s) Generic name etc : mFOLFOX6 + bevacizumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): 1.Overall survival (OS) for All Participants Timeframe: Up to approximately 60 months OS will be measured as the time from the date of randomization to the date of death due to any cause. 2.OS for Participants with Left-sided Tumors Timeframe: Up to approximately 60 months OS will be measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. Study Design: Randomized controlled trial, open, active control, parallel assignment

DISEASE(S): Colorectal Cancer

PROVIDER: 97964 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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An exploratory study of treatment sensitivity and prognostic factors in a efficacy and safety study of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naive unresectable advanced or recurrent colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : mFOLFOX6 + panitumumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks control material(s) Generic name etc : mFOLFOX6 + bevacizumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

| 97976 | ecrin-mdr-crc

Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (PARADIGM study)

Project description:Intervention name : mFOLFOX6 + panitumumab INN of the intervention : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Dosage And administration of the intervention : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks Control intervention name : mFOLFOX6 + bevacizumab INN of the control intervention : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Dosage And administration of the control intervention : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): efficacy Overall survival (OS) for All Participants Timeframe: Up to approximately 63 months OS will be measured as the time from the date of randomization to the date of death due to any cause. efficacy OS for Participants with Left-sided Tumors Timeframe: Up to approximately 63 months OS will be measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. Study Design: Randomized controlled trial, open, active control, parallel assignment

| 2611228 | ecrin-mdr-crc

Project description:Intervention name : mFOLFOX6 + panitumumab INN of the intervention : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Dosage And administration of the intervention : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks Control intervention name : mFOLFOX6 + bevacizumab INN of the control intervention : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Dosage And administration of the control intervention : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

| 2658055 | 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 I study of TAS-102 and irinotecan

Project description:Interventions: investigational material(s) Generic name etc : TAS-102 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). control material(s) Generic name etc : irinotecan INN of investigational material : irinotecan Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

| 100929 | ecrin-mdr-crc

A phase III, randomized, controlled study of mFOLFOX6 + bevacizumab combination therapy versus mFOLFOX6 + panitumumab combination therapy in chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer

Project description:Interventions: mFOLFOX6 + panitumumab mFOLFOX6 + bevacizumab Primary outcome(s): 1. Overall survival (OS) 2. OS for Participants with Left-sided Tumors Study Design: Parallel Randomized

| 2632097 | 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

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

| 100333 | 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 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

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