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

ABSTRACT: 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2625119 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

Project description: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

| 2623200 | ecrin-mdr-crc

Transcription profiling of rectal adenocarcinomas biopsied before and after pre-operative short-course radiotherapy or 5-flurouracil-based chemoradiotherapy

Project description:The molecular mechanisms of clinical response or resistance to therapy were evaluated in colorectal cancer patients in a prospective biomarker discovery project. Rectal adenocarcinomas, biopsied before (diagnostic biopsy) and after (surgical resection) pre-operative short-course radiotherapy [RT] or 5-flurouracil (5-FU)-based chemoradiotherapy [CRT], were profiled using Affymetrix HGU133 Plus 2.0 microarrays. Tumour tissues from untreated controls at diagnosis and surgical resection were used to identify treatment-independent gene expression changes. Candidate resistance biomarkers were identified in this pilot study for validation in a larger cohort.

2009-11-10 | E-MEXP-1901 | biostudies-arrayexpress

Peri-operative chemotherapy for resectable colorectal lung metastasis: a systematic review and meta-analysis.

Project description:PURPOSE:Several studies have evaluated surgical resection of pulmonary metastases as a standard treatment option for colorectal cancer (CRC) patients with resectable pulmonary metastases. However, the role of peri-operative chemotherapy after complete resection of pulmonary metastases from CRC patients is still controversial. This systematic review and meta-analysis is aimed to investigate the clinical efficacy of peri-operative chemotherapy after resection of CRC pulmonary metastases. METHODS:PubMed, the Cochrane Library databases, and Embase were searched for studies evaluating the effect of peri-operative chemotherapy on the survival of patients with CRC after pulmonary metastasectomy. The hazard ratio (HR) was used for analyzing overall survival (OS) and progression-free survival (PFS)/recurrence-free survival (RFS)/disease-free survival (DFS). RESULTS:Eight studies were included in the final analysis. The outcome showed that peri-operative chemotherapy had a significant favourable effect on OS (HR 0.83, 95% CI 0.75-0.92, p < 0.05) and PFS/RFS/DFS (HR 0.67, 95% CI 0.53-0.86, p < 0.05) in patients who received pulmonary metastasectomy. Multivariate analysis also validated this result (OS: HR 0.56, 95% CI 0.36-0.86, p < 0.05; PFS/RFS/DFS: HR 0.64, 95% CI 0.46-0.87, p < 0.05). There was a significant benefit in peri-operative group on OS and PFS/RFS/DFS in studies with R0 resection of pulmonary metastases (OS: HR 0.72, 95% CI 0.53-0.97, p < 0.05; PFS/RFS/DFS: HR 0.72, 95% CI 0.54-0.95, p < 0.05) and metachronous pulmonary metastases (OS: HR 0.40, 95% CI 0.22-0.75, p < 0.05; PFS/RFS/DFS: HR 0.67, 95% CI 0.49-0.92, p < 0.05). CONCLUSION:Our meta-analysis demonstrated a significant difference in favor of peri-operative chemotherapy in CRC patients who underwent resection of pulmonary metastases. More clinical data and studies are needed to validate the findings of our study.

| S-EPMC7039839 | biostudies-literature

Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC).

Project description:Interventions: Pre-operative chemotherapy(FOLFIRI3 plusCetuximab)4cycles =>To evaluate effect =>Surgical resection or Continued chemotherapy =>Surgical resection. *FOLFIRI3 plus Cetuximab Cetuximab500 mg/m2/day1/q2w CPT-11 100 mg/m2/day1,3/q2w I-LV 200 mg/m2/day1/q2w 5-FU/infusional 2400 mg/m2/46hr/q2w Primary outcome(s): Treatment completion rate Study Design: Single arm Non-randomized

| 2625026 | ecrin-mdr-crc

Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)

Project description:Interventions: A: Live resection B: At 56 to 84 days after hepatectomy, patients receive 2-hour infusion of oxaliplatin IV and l-leucovorin on day 1 followed by fluorouracil (5-FU) bolus and 46-hour infusion on day 1. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. Primary outcome(s): Treatment compliance at 9 courses after beginning mFOLFOX6 (phaseII) Disease-free survival (phaseIII) Study Design: Parallel Randomized

| 2616158 | ecrin-mdr-crc

JCOG0603: Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer

| 2614114 | 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

Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety

Project description:The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.

| 2115192 | ecrin-mdr-crc

RNA-sequencing in skeletal muscle from a mouse model of laparotomy with pre-operative running wheel exercise

Project description:This study aimed to characterize the effects of pre-operative volitional running wheel exercise on post-operative physical function and skeletal muscle gene expression in 24-month-old C57BL/6N mice following laparotomy. Soleus muscles collected on post-operative day 5 (POD 5) were used for this study.

2022-04-28 | GSE201252 | GEO

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

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