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Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)

ABSTRACT: Interventions: FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred. Goshajinkigan(GJG) is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion. FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred. Placebo is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion. Primary outcome(s): The incidence of peripheral neurotoxicity ≥grade 2 after eight cycles of chemotherapy. Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2617692 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer

Project description:Interventions: FOLFOX4(L-OHP85mg/m2,l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU2400mg/m2(civ)). Ca/Mg 0.8-1g (iv) x2 before and after L-OHP infusion Cycles of therapy are given every 2 weeks for 12 cycles Primary outcome(s): the rate of completion of treatment as planned Study Design: Single arm Non-randomized

| 2619165 | ecrin-mdr-crc

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

2013-01-01 | GSE41998 | GEO

Comparative Analysis of Transcriptional RNA Expression in HEK293T Cells Transfected with the H3N2 Subtype Canine Influenza Viruses M1/M2 and Canine RIG-I

Project description:Our previous study revealed that influenza virus matrix protein 1 (M1)and matrix 2 (M2) interacted with canine RIG-I. However, the influence of these interactions remains in the mist. To explore these cellular transcriptome modulation induced by the interaction between CIV M1/M2 and canine RIG-I, here we carried out the comparative transcriptional RNA analysis of the overexpression of CIV M1/M2 along with canine RIG-I in HEK 293T cells.

2024-10-21 | GSE186299 | GEO

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

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

Project description:A randomized, open-label, multicenter, phase II trial (NCT00455533) enrolled previously untreated women with histologically-confirmed primary invasive breast adenocarcinoma (T2–3, N0–3, M0, tumor size ≥2.0 cm), regardless of hormone receptor or HER2 expression status. Patients received sequential neoadjuvant therapy starting with 4 cycles of AC (doxorubicin 60 mg/m2 intravenously and cyclophosphamide 600 mg/m2 intravenously) given every 3 weeks, followed by 1:1 randomization to either ixabepilone (40 mg/m2 3-hour infusion) every 3 weeks for 4 cycles, or paclitaxel (80 mg/m2 1-hour infusion) weekly for 12 weeks. Fresh tumor biopsies at screening were a mandatory prerequisite for study entry for biomarker analyses. Gene expression profiling was performed by Affymetrix GeneChip to determine if pre-specified gene models could distinguish between the clinical activity of two microtubule stabilizing agents, ixabepilone and paclitaxel. Three core needle tumor tissue biopsies were obtained from all subjects before neoadjuvant therapy with AC and immediately combined in RNAlater® solution for subsequent RNA extraction, cRNA labeling and gene expression profiling. Pre-specified gene models were tested for their capacity to distinguish pathologic complete response rates between the AC followed by ixabepilone versus the AC followed by paclitaxel treatment regimens. All samples were collected prior to treatment. All subject received cyclophosphamide/doxorubicin (AC) prior to randomization to either Ixabepilone or Paclitaxel.

2013-01-01 | E-GEOD-41998 | biostudies-arrayexpress

Budding yeast respiratory oscillations in a transient state

Project description:RNAseq analysis of budding yeast respiratory oscillations was performed at high temporal resolution (4 min, 24 samples), covering 2.5 cycles of the short period oscillation of the IFO 0233 strain of budding yeast. This and related systems were previously analyzed by microarrays and RNAseq, but the expression of noncoding transcripts has not been analyzed. The oscillations were recorded by online measurements and the system underwent a multi-generational transient, where periods first gradually decreased (from 0.7 h to 0.6 h), and then a bifurcation of system dynamics occurred. After this bifurcation periods were longer but the oscillation was unstable. The RNAseq samples were taken in the 2.5 cycles before this bifurcation occurred, i.e., the data provides a snapshot of a transient state of the respiratory oscillations.

2022-07-11 | E-MTAB-11901 | biostudies-arrayexpress

A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Intervention name : L-OHP (Oxaliplatin) INN of the intervention : oxaliplatin Dosage And administration of the intervention : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Intervention name : BV (Bevacizumab) INN of the intervention : bevacizumab Dosage And administration of the intervention : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks Control intervention name : 5-FU (Fluorouracil) INN of the control intervention : fluorouracil Dosage And administration of the control intervention : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Control intervention name : l-LV (Levofolinate calcium) INN of the control intervention : folic acid Dosage And administration of the control intervention : 200 mg IV on day 1. Repeat cycles every 2 weeks. Control intervention name : L-OHP (Oxaliplatin) INN of the control intervention : oxaliplatin Dosage And administration of the control intervention : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Control intervention name : BV (Bevacizumab) INN of the control intervention : bevacizumab Dosage And administration of the control intervention : 5 mg/kg IV on day 1. Repeat cycles every 2 weeks. Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

| 2610116 | ecrin-mdr-crc

A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation in patients with simultaneous primary and metastatic rectal cancer

Project description:Interventions: Single arm study - Integrated preoperative radiotherapy and chemotherapy over 11 weeks. Treatment: drugs Oxaliplatin (given intravenously): day 1 of each of weeks 1, 6 and 11 100mg/m2 given; day 1 of each of weeks weeks 3 and 8, 85 mg/m2 given. Flurouracil: day 1 of each of weeks 1, 6 and 11 400mg/m2 bolus, given intravenously followed on day 1 by continuous infusion 2.4 g/m2, over 46 hours; on days of radiotherapy during both weeks 3-5 and weeks 8-10 - continuous infusion 200mg/m2/day over 96 hours Leucovorin (given intravenously): day 1 of each of weeks 1, 6 and 11 200mg/m2 given. Bevacizumab (given intravenously): day 1 of each of weeks 1, 3, 5, 7, 9 and 11 - 5mg/kg Treatment: Other Radiation Therapy: in both weeks 3-5 and weeks 8-10 25.2Gy in 14 fractions over 2 weeks and 4 days. A total of 50.4 Gy in 1.8 Gy per fraction is given. The first 45 Gy is given to the pelvic volume and the final 5.4 Gy is given to a boost volume. Primary outcome(s): Tolerability rate: the percentage of patients who are able to complete the planned treatment program and do not require a treatment break for toxicity.[End of the treatment program (11 weeks)] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

| 2456506 | ecrin-mdr-crc

Molecular Subtype Predicts Response to Neoadjuvant Chemotherapy in Breast Cancer

Project description:In a prospective cohort study of 32 women with primary invasive breast cancer with a measurable lesion, we obtained a tumor specimen by high speed core biopsy before and after 4 cycles of NAC with epirubicine 90mg/m2 and cyclophosphamide 600mg/m2 every 3 weeks, followed by 4 cycles of docetaxel 100mg/m2. Total RNA was extracted from tumor specimens and the whole transcriptome was quantified with Agilent’s 44K single color microarray interrogating 41000 unique human genes. Tumor lesions were ultrasonographically measured to assess response using Sinn criteria. Genes significant different and significant changing during chemotherapy accompanying and predicting response were searched.

2010-05-25 | GSE21974 | GEO

To assess the safety and tolerability of a single oral dose of the Capecitabine test and reference formulations

Project description:Intervention1: Capecitabine Tablets 500 mg, manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Intervention2: Capecitabine Tablets 500 mg,manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Control Intervention1: XelodaÂ (Capecitabine) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080): The recommended dose of XELODAÂ is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Primary outcome(s): Establishing the bioequivalence between test and referenceTimepoint: Day 1 and Day 2

| 2573933 | ecrin-mdr-crc

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