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

ABSTRACT: 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

DISEASE(S): Unresectable Stage Iv Colorectal Cancer And A Synchronous Asymptomatic Primary Tumor

PROVIDER: 2623557 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial

Project description:Interventions: capecitabine plus intermittent oxaliplatin (CapeOx) in combination with Bevacizumab: (CapeOx + Bevacizumab)x5 cycles followed by (Capecitabine + Bevacizumab )x5 cycles, followed by (CapeOx + Bevacizumab)x5 cycles are administered until progression. [CapeOx + Bevacizumab] Capecitabine: 2000mg/m2/day p.o. (day1-15) Oxaliplatin: 130mg/m2 i.v. (day1) Bevacizumab: 7.5mg/kg i.v. (day1) to be repeated every 3 weeks [Capecitabine + Bevacizumab] Capecitabine: 2000mg/m2/day p.o. (day1-15) Bevacizumab: 7.5mg/kg i.v. (day1) to be repeated every 3 weeks Primary outcome(s): progression free survival (PFS) Study Design: Single arm Non-randomized

| 2621169 | ecrin-mdr-crc

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: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

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| 97976 | ecrin-mdr-crc

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

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| 2611228 | 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

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| 2739106 | ecrin-mdr-crc

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

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| 97964 | ecrin-mdr-crc

A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab

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| 2105511 | ecrin-mdr-crc

Switch Maintenance Study

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| 2612965 | ecrin-mdr-crc

Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer

Project description:Interventions: UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest. CPT-11 150mg/m2/day is given intravenously on day 1 and 15 of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities. The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities.FOLFIRI consisted of CPT-11 150 mg/m2 IV over 90 minutes, LV 400 mg/m2 IV over 2 hours, and FU 400 mg/m2 IV bolus, followed by FU 2.400mg/m2 IV over a 46-hour infusion, repeated every 2 weeks. Cycles are repeated every 4 weeks, until evidence of disease progression or severe toxicities. UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive day followed by a 7 days rest. CPT-11 and Bevacizumab are given intravenously on day 1 and 15 of each cycle. Bevacizumab is added dilute to 100mL with physiological salt solution and given intravenously over 90 minutes. After the tolerability of the initial administration time is confirmed, the time can be shortened to 60 minutes. After the tolerability of the second administration time is confirmed, the time can be shortened to 90 minutes. After the administration of Bevacizumab, CPT-11 150mg/m2/day is given Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities. The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities. Bevacizumab is added dilute to 100mL with physiological salt solution and give Primary outcome(s): Step1 Toxicity Step2 Progression-free survival Study Design: Parallel Randomized

| 2616452 | ecrin-mdr-crc

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