XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): C04.588.274.476.411.307,Colorectal Neoplasms
PROVIDER: 2020447 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:The Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC) trial reported an acceptable safety profile for neoadjuvant Oxaliplatin and Capecitabine (Xelox) +/- AZD8931 in oesophageal adenocarcinoma (OAC) but limited efficacy. We evaluated the impact of neoadjuvant Xelox +/-AZD8931 on biological pathways using a unique software-driven solution. Transcriptomic profiles from 25 pre-treatment FFPE OAC biopsies and 17 matched resection specimens, treated with Xelox+AZD8931 (n=16) and Xelox alone (n=9), were analysed using the Almac claraT total mRNA report. Tumour Infiltrating Lymphocytes (TILs) were assessed digitally using QuPath software. Hierarchical clustering identified three molecular subgroups classified by activation of innate immune signalling. The Immune High subgroup was associated with HER2 positivity, increased pathological response and a marked reduction in immune signalling and TILs following neoadjuvant therapy. The Immune Low cluster was pre-dominantly HER2/EGFR negative and EGFR positivity was associated with the Immune Mixed subgroup. Neoadjuvant therapy induced angiogenesis and EMT signalling and a reduction in DNA repair signatures with AZD8931 also promoting an immunosuppressive microenvironment. OAC may be subdivided into three immune-related subgroups which undergo modulation in response to neoadjuvant therapy with marked suppression of the immune microenvironment in HER2 positive/Immune High tumours.
2024-09-01 | E-MTAB-13741 | biostudies-arrayexpress
Project description:In many organisms, the circadian clock is composed of functionally coupled morning and evening oscillators that regulate the bouts of dawn and dusk activity. In Arabidopsis, oscillator coupling relies on a core loop in which the evening oscillator component TOC1 was proposed to activate a subset of morning-expressed oscillator genes. Our systems-biological approach overturns the current view of the Arabidopsis circadian clock showing that TOC1 does not function as an activator but as a timely-controlled general repressor of morning and evening oscillator components. Repression occurs through rhythmic binding to the promoters of all oscillator genes, suggesting a previously unexpected direct connection between the morning and evening loops.
2012-03-08 | GSE35952 | GEO
Project description:Interventions: (XELOX) Xeloda: 1000 mg/m2 twice daily [by mouth (p.o.), morning and evening within 30 min of last meal], days 1 to 14 Oxaliplatin: 130 mg/m2 by 2-hour intravenous (IV) infusion, day 1
The treatment will commence in 4-6 weeks after surgery. Repeat every 21 days for 8 cycles
Primary outcome(s): To compare the 3-year DFS (disease free survival) between the two group therapies [Xeloda and Oxaliplatin (XELOX) versus 5-FU/Leucovorin and Oxaliplatin (FOLFOX)] in patients with colorectal cancer of stage B2 (high risk) and C, according to Dukes[Disease-free survival will be assessed in each patient by history and physical examination at each cycle and by history, physical examination, serum tumor markers [Carcinoembryonic Antigen (CEA), Carbohydrate Antigen 19-9 (CA19-9)], computed tomography of the abdomen and pelvis and chest x-rays every 4 months and endoscopy every 1 year during follow-up. The final outcome will be assessed 3 years after the enrollment of the last patient at the study.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial
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Project description:In many organisms, the circadian clock is composed of functionally coupled morning and evening oscillators that regulate the bouts of dawn and dusk activity. In Arabidopsis, oscillator coupling relies on a core loop in which the evening oscillator component TOC1 was proposed to activate a subset of morning-expressed oscillator genes. Our systems-biological approach overturns the current view of the Arabidopsis circadian clock showing that TOC1 does not function as an activator but as a timely-controlled general repressor of morning and evening oscillator components. Repression occurs through rhythmic binding to the promoters of all oscillator genes, suggesting a previously unexpected direct connection between the morning and evening loops. Examination of TOC1 genome-wide binding using TOC1 Minigene (TMG) seedlings expressing the genomic fragment of TOC1 fused to the Yellow Fluorescent Protein in a toc1-2 mutant background (TMG-YFP/toc1-2 seedlings) grown under LD cycles (12h light:12h dark).
2012-03-08 | E-GEOD-35952 | biostudies-arrayexpress
Project description:To better understand how diurnal transcriptional regulation contributes to day/night cycles of volatile emission from the petunia flower, cross-linked chromatin from corolla in the morning (7AM) and evening (7PM) was immunoprecipitated with antibodies against 4 histone marks associated with trancriptional activity to determine islands enriched for the marks in morning and evening.
2023-11-08 | GSE230857 | GEO
Project description:Intervention 1: Intervention group:Xelox diet group.Includes a 2-hour intravascular injection. Oxaliplatin injection of 130 mg / m2 on day 1 plus oral capsaicin 1000 mg / m2 twice daily on days 15-1 of the 3-week cycle on an outpatient basis. The first dose of capsaicin is given in the evening of day 1 and the last dose in the morning on day 15 (28 doses per cycle). Intervention 2: Control group:Folfox diet group.Includes weekly injections of 5 FU 500 mg / m2, Leucovorin 500 mg / m2 for 6 weeks and oxaliplatin 85 mg / m2 at weeks 1, 3, 5, repeated for 3 periods.
Primary outcome(s): Local recurrence. Timepoint: One year period. Method of measurement: Colonoscopy.;Distant metastasis. Timepoint: One year period. Method of measurement: Tumor marker and CT scan.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups a and b using the balance block randomization method. The size of each block is 4. The method of balanced randomization allocation for participants in a randomized clinical trial study is the effect of Xelox (group a) and Folfox (group b) chemotherapy on reducing local recurrence and distant metastasis of non-metastatic colon cancer patients.The tool is random allocation software.
| 2727549 | ecrin-mdr-crc
Project description:Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC).
Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.
Test products:
Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity.
Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.
| 2027879 | ecrin-mdr-crc
Project description:Intervention1: 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil Tablet.: Manufactured by NATCO Pharma Ltd. orally twice daily with approximately 240 mL (8 fluid ounces) of water at ambient temperature after an overnight fast of at least 10 hours Prior to morning dosing and fasting of at least 02 hours prior to evening dosing (except the standard test meal administered 30 minutes prior to dosing) within 30 minutes of completion of morning and evening meals on Cycle 1 (Days 1 through 5) OR Cycle 1 (Day 8 through 12) or Cycle 2 (Days 1 through 5) based on the randomization Schedule.
Control Intervention1: LONSURF Tablet; 35 mg/m2 of Trifluridine; Tipiracil Tablet(15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil tablet ): Manufactured by Taiho Pharmaceutical Co., Ltd., Japan. Manufactured for Taiho Oncology, Inc. Princeton, NJ 08540 USA. orally twice daily with approximately 240 mL (8 fluid ounces) of water at ambient temperature after an overnight fast of at least 10 hours Prior to morning dosing and fasting of at least 02 hours prior to evening dosing (except the standard test meal administered 30 minutes prior to dosing) within 30 minutes of completion of morning and evening meals on Cycle 1 (Days 1 through 5) OR Cycle 1 (Day 8 through 12) or Cycle 2 (Days 1 through 5) based on the randomization Schedule
Primary outcome(s): To assess relative bioavailability of 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil Tablet, compared to LONSURF (15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil) Tablet, following multiple dose in Metastatic colorectal cancer patients who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy.Timepoint: 33 Days
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Project description:Intervention1: Capecitabine (CJSC Biocad) tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Capecitabine will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast).
Control Intervention1: Xeloda (Capecitabine)tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Xeloda will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast).
Primary outcome(s): Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug:
Area under capecitabine «concentration-time» curve at the time of the drug administration up to 12 hours (AUC(0-12))
Timepoint: 0 min, 15 mins, 30 mins, 45 mins, 1hr, 1hr 30 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 10 hrs and 12 hrs after administration of the test or reference drug.
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
| 2574596 | ecrin-mdr-crc
Project description:Intervention1: XELODAÂ -Capecitabine 500 mg tablets: Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days including of three study periods.
Control Intervention1: Capecitabine 500 mg tablets: Capecitabine 1250 mg/m2 administered twice daily orally; BD morning and evening; equivalent to 2500 mg/m2 total daily dose for 14 days including of three study periods.
Primary outcome(s): To characterize the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Cadila Heathcare Limited, India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Manufactured by Genentech USA Inc. USA) in patients of Metastatic Breast Cancer, Dukes C Colon Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: Time points are 30 minutes prior to drug dosing and at 0.25hr, 0.50hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 5hr, 6hr, 8hr and 10 hours post-dose.
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
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