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Systemic oxaliplatin or in intra-arterial chemotherapy combined with LV5FU2 +/- Irinotecan and targeted therapy in first-line treatment of metastatic colorectal cancer restricted to the liver

ABSTRACT: Primary objectives: Comparison of radiological and/or clinical progression free survival between the arm with intraarterial oxaliplatin administration (Arms A and C) and those with intravenous oxaliplatin administration (Arms B and D). Progression was assessed according to the criteria RECIST v1.1 and according to the investigator. Primary endpoints: Progression free survival (median)

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Cancer With Hepatic Metastasis,Colorectal Cancer Metastatic,Cancer Colorectal Métastatique Au Niveau Hépatique

PROVIDER: 2744502 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

Project description:Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.

| 2223852 | ecrin-mdr-crc

A multicenter randomized phase 2 study to compare the efficacy and safety of avelumab versus standard second line treatment, in patients with metastatic colorectal cancer (MMR) after first line treatment progression.

Project description:Primary objectives: Compare between the two treatment arms (arm A: 2nd line chemotherapy, arm B: avelumab) progression-free survival by central review (RECIST 1.1 for Arm A and iRECIST for arm B) Primary endpoints: The primary endpoint is radiographic progression-free survival (PFS). The progression will be assessed by central review according to the criteria RECIST v1.1 in arm A and according to the criteria irRECIST in arm B.PFS is defined as the time between the date of randomization and the date of the first radiological progression or the date of death (for whatever reason). Patients living without radiological progression will be censured on the date of their latest x-ray.

| 2536396 | ecrin-mdr-crc

Genomic landscape of metastatic colorectal cancer

Project description:Response to drug therapy in individual colorectal cancer (CRC) patients is associated with tumor biology. Here we describe the genomic landscape of tumor samples of a homogeneous well-annotated series of patients with metastatic CRC of two phase III clinical trials, CAIRO and CAIRO2. DNA copy number aberrations of 349 patients are determined. Within three treatment arms, 194 chromosomal sub-regions are associated with progression free survival PFS (uncorrected single-test p-values < 0.005). These sub-regions are filtered for effect on mRNA expression, using an independent data set from The Cancer Genome Atlas (TCGA) which returned 171 genes. Three chromosomal regions are associated with a significant difference in PFS between treatment arms with or without irinotecan. One of these regions, 6q16.1-q21, correlates in vitro with sensitivity to SN-38, the active metabolite of irinotecan. This genomic landscape of metastatic CRC reveals a number of DNA copy number aberrations associated with response to drug therapy. aCGH data of colorectal cancers of patients from 2 clinical trials (CAIRO, CAIRO2). 105 patients were treated with capecitabine first line (CAIRO arm A), 111 patients were treated with capecitabine and irinotecan first line (CAIRO arm B), and 133 patients were treated with capecitabine, oxaliplatin and bevacizumab (CAIRO2 arm A).

2014-11-14 | E-GEOD-36864 | biostudies-arrayexpress

Prospective study in patients with cancer of the colon or rectum with liver metastasis, of the efficacy and toxicity of standard therapy (chemotherapy + targeted therapy) combined with immunotherapy and internal radiotherapy targeting the liver

Project description:Primary objectives: Evaluate the progression-free survival at 9 months (according to RECIST 1.1) according to the investigator. Primary endpoints: Progression-free survival at 9 months: percentage of patients alive and without a radiological progression (whatever the type of radiological progression: hepatic or extra-hepatic) 9 months after inclusion (using RECIST v1.1 criteria) according to the investigator

| 2539311 | ecrin-mdr-crc

Whole genome copy number profiles of FFPE samples from patients with metasatic colorectal cancer (mCRC)

Project description:Metastatic colorectal cancer (mCRC) is associated with multiple somatic copy number alterations (SCNAs). We analyzed SCNAs to estimate overall survival (OS) and progression free suvival (PFS) for mCRC patients treated with bevacizumab in combination with oxaliplatin or irinotecan.

2018-11-21 | GSE110785 | GEO

mRNA expression of spinal dorsal horn in oxaliplatin-treated rats

Project description:Oxaliplatin-induced neuropathic pain is a common dose-limiting side effect of cancer treatment but the underlying mechanisms are largely unknown. The neuropathic pain model was established by oxaliplatin intraperitoneal administration for five consecutive days. In the present study, we performed whole genome expression microarray analysis by using spinal dorsal horn from oxaliplatin-treated and vehicle-treated rats on day 10.

2020-03-11 | GSE146739 | GEO

Response to oxaliplatin in CCD-18Co

Project description:We obtained the gene expression signature from oxaliplatin-treated fibroblasts and quantified the association of oxaliplatin-activated fibroblasts with disease progression in colorectal cancer.

2023-01-16 | GSE181020 | GEO

Avelumab added to FOLFIRI plus Cetuximab followed by Avelumab maintenance in patients with previously untreated RAS wild-type colorectal cancer - The phase II FIRE-6-Avelumab study

Project description:Primary objectives: The primary objective of the study is to assess the efficacy of FOLFIRI plus cetuximab incombination with avelumab followed by avelumab maintenance therapy in patients withpreviously untreated RAS/BRAF wild-type mCRC. Primary endpoints: • Progression-free survival (PFS) according to RECIST v1.1

| 2538194 | ecrin-mdr-crc

Expression data from oxaliplatin-treated tumors from mice pre-treated or not with antibiotics cocktail

Project description:The gut microbiota influences both local and systemic inflammation. Inflammation contributes to development, progression and treatment of cancer, but it remains unclear whether commensal bacteria affect inflammation in the sterile tumor microenvironment. Here we show that disruption of the microbiota impairs the response of subcutaneous tumors to CpG-oligonucleotide immunotherapy and platinum chemotherapy. In antibiotic-treated or germ-free mice, tumor-infiltrating myeloid-derived cells responded poorly to therapy, resulting in lower cytokine production and tumor necrosis after CpG-oligonucleotide treatment, and deficient production of reactive oxygen species and cytotoxicity following chemotherapy. Thus, optimal responses to cancer therapy require an intact commensal microbiota that mediates its effects by modulating myeloid-derived cell functions in the tumor microenvironment. These findings underscore the importance of the microbiota in the outcome of disease treatment. Oxaliplatin treatment induces expression of pro-inflammatory genes, which are inhibited by antibiotic pretreatment. Our goal was to ascertain the effect of antibiotic on the tumor gene expression profile prior to treatment and early on after the treatment with chemotherapy (oxaliplatin). The time points were selected t

2013-12-03 | E-GEOD-51414 | biostudies-arrayexpress

NIVOLUMAB plus IPILIMUMAB and TEMOZOLOMIDE in combination in metastatic colorectal cancer.

Project description:Primary objectives: To evaluate the efficacy, measured as 8-month PFS rate, of the combination of TMZ, NIVO and IPI in patients achieving disease control following 2-month lead-in treatment with single agent TMZ. Primary endpoints: The primary efficacy endpoint of this study is the 8-month Progression Free Survival (PFS) rate, defined as the proportion of patients alive and progression-free.The efficacy outcome measures for this study are as follows:• Investigator-assessed PFS according to RECIST v1.1• Investigator-assessed PFS according to modified RECIST

| 2538691 | ecrin-mdr-crc

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