Regorafinib escalation for colorectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Metastatic Colorectal Cancer
PROVIDER: 2644127 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: investigational material(s)
Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin)
INN of investigational material : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
control material(s)
Generic name etc : UFT(tegafur + uracil) LV (Folic acid)
INN of investigational material : UFT: tegafur, uracil LV:folic acid
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
Primary outcome(s): efficacy
Disease-free survival (DFS)
Study Design: Randomized, open-label, comparative study
| 97801 | ecrin-mdr-crc
Project description:Intervention name : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin)
INN of the intervention : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin
Dosage And administration of the intervention : S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
Control intervention name : UFT(tegafur + uracil) LV (Folic acid)
INN of the control intervention : UFT: tegafur, uracil LV:folic acid
Dosage And administration of the control intervention : UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
Primary outcome(s): efficacy
Disease-free survival (DFS)
Study Design: Randomized, open-label, comparative study
| 2610281 | ecrin-mdr-crc
Project description:Six-week-old control mice and VDR CKO mice were administered tamoxifen (100 mg/kg body weight) via intraperitoneal injection once daily for five consecutive days. After a two-week interval, mice of each genotype were randomly allocated into two groups: the saline group and the BLM group. On day 0, mice in the BLM subgroup received an intratracheal injection of BLM (1 mg/kg), while those in the saline subgroup were given an equivalent volume of saline via intratracheal injection. All mice were euthanized on day 21, and their lungs were harvested for 4D label-free quantitative proteomics analysis.
| PXD078654 |
Project description:Two separate experiments were performed. Experiment 1: Mice were subcutaneously injected with either B16F10 or B16KVP tumors. 6 days later, they were given 5Gy total body irradiation as a lymphdepletion regimen. Then the next day, 500,000 naïve pmel-1 CD8 T cells were injected via the tail vein into these mice. 5 days after adoptive cellular therapy, these mice were sacrified and the tumors and tumor draining lymph nodes harvested for Nanostring analysis. Experiment 2: Mice were subcutaneously injected with either B16F10 or B16KVP tumors. 6 days later, they were given 5Gy total body irradiation as a lymphdepletion regimen. Then the next day, mice were given no treatment or 500,000 naïve pmel-1 CD8 T cells were injected via the tail vein into these mice. 5 days after adoptive cellular therapy, these mice were sacrified and the tumors harvested for Nanostring analysis.
2025-11-18 | GSE285952 | GEO
Project description:Interventions: Panitumumab with irinotecan/S-1(IRIS) S-1,80-120mg/body for twice daily 14 consecutive days followed by 2 weeks rest combined with intravenous CPT-11 100mg/m^2 and P-mab 6mg/kg(weight) given on day1,15 every 4 weeks until disease progression or unmanageable toxicity.
Primary outcome(s): Response rate
Study Design: Single arm Non-randomized
| 2623902 | ecrin-mdr-crc
Project description:Interventions: A: UFT/LV group
UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
B: SOX group
S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
Primary outcome(s): Disease-free survival
Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
| 2614159 | ecrin-mdr-crc
Project description:<p>The Study to Assess the Cardiovascular, Cognitive, and Subjective Effects of Atomoxetine in Combination with Intravenous Methamphetamine started in 2007 and ended in 2011. It was a small pilot study that included methamphetamine abusing individuals and healthy control participants aged 18-50 years. Participants who qualified over the telephone were scheduled to visit the London Laboratory at the UCLA Semel Institute for Neuroscience and Human Behavior for the In-Person Screening Phase. The screening procedures, usually scheduled over two visits, determined if participants were eligible to complete the subsequent study visits. Both groups completed identical screening procedures, including a SCID diagnostic interview to rule out any major psychiatric disorders. Methamphetamine users also answered questionnaires specific to their drug use. Urine toxicology for marijuana, opiates, cocaine, methamphetamine, and benzodiazepines were monitored at the beginning and throughout the study. Additionally, participants had blood samples to test for Rapid Plasma Reagin (exposure to syphilis), purified protein derivative (PPD), HIV and Hepatitis-C (HCV). Positive test results were relayed by a study physician and resulted in termination from continuing in the study.</p> <p>The inpatient portion of the study lasted a total of 24 days. To confirm compliance with abstinence from illicit and prescription drug use for the duration of the study, urine and breath alcohol testing was performed for both inpatient (methamphetamine users) and outpatient (healthy control) groups. Each subject was randomized to receive either atomoxetine (80 mg daily) or placebo. During inpatient days of the study, a study physician oversaw research subjects daily and experimental procedures were conducted in the General Clinical Research Center (GCRC). During drug administration sessions, heart rate and blood pressure were assessed at frequent intervals. Experimental sessions lasted around three hours and were conducted at approximately the same time of day for a given participant. Lunch was provided to participants at 11:30am with the prohibition of caffeine on study days involving methamphetamine administration. Participants were provided with smoke breaks as needed to assure that acute nicotine withdrawal did not negatively impact performance on cognitive testing. The following outlines the day to day procedures for a methamphetamine inpatient:</p> <p><b>Phase I Inpatient Study</b> (<i>15 days total</i>)<br/> <b>Days 1-3:</b> On the day of admission, participants received blood tests and an EKG in order to determine that they had no occult medical conditions which would make their participation in the study medically contraindicated. A three day washout period was provided at the beginning of the study to establish an appropriate methamphetamine-free baseline for testing. <br/> <b>Days 4-6:</b> Participants completed cognitive test batteries to assess inhibitory control including self-report measures and cognitive testing, as well as up to three MRI scanning sessions.<br/> <b>Day 7:</b> On day 7, at 9AM and 1PM, participants received methamphetamine in a single-blinded condition. It was administered as two IV infusions of 15mg separated by a 60min break. The total dose of IV methamphetamine was 30mg. Participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in the absence of study medication.<br/> <b>Day 8:</b> On day 8 we evaluated the safety and residual effects of the methamphetamine administered on the previous day.<br/> <b>Days 9-10:</b> After demonstrating medical and psychiatric stability of the initial methamphetamine infusion, participants were then randomized to receive placebo or atomoxetine (0 or 40mg) under double-blind conditions, which would be given at 8AM on both study days. <br/> <b>Days 11-12:</b> On days 11 and 12, participants remained in the GCRC and took two doses of test compound atomoxetine (0 or 40mg) at 8AM and 8PM. On the morning of day 12, participants completed a series of cognitive testing.<br/> <b>Day 13:</b> On day 13, participants remained in the GCRC, and took two doses of the test compound atomoxetine (0 or 40mg) at 8AM and 8PM. At 9AM and noon, they received methamphetamine under double-blind conditions administered non-contingently as two infusions of 0 or 15mg by IV (intravenously), with each infusion separated by 60min. The total dose of IV methamphetamine that each participant received was 30mg. As before, participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in those participants receiving study medication. <br/> <b>Day 14:</b> On day 14 at 8AM, participants received their final dosing of the first test compound (atomoxetine 0 or 40mg). At 9AM and 1PM, participants selected between methamphetamine infusion or money using double-blind conditions in a multiple-choice self-administration paradigm. Participants were able to take up to two infusions of 0 or 15mg of methamphetamine, separated by 60min. The total dose of IV methamphetamine that each participant received on day 14 was 30mg. Participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in those participants receiving study medication. At 5pm on day 14 discharge laboratory studies were drawn.<br/> <b>Day 15:</b> On day 15, a final EKG was performed as well as a review of discharge laboratory studies, including review of the EKG and continued medical and psychiatric stability. Upon clearance from a physician, participants were discharged on day 15. Participants spent at least 2 weeks (14 days) out of the hospital prior to returning to the UCLA GCRC for inpatient Phase II.<br/></p> <p><b>Phase II Inpatient Study</b> <i>(9 days total)</i><br/> <b>Day 1-2:</b> On the day of re-admission, participants received blood tests and an EKG. A two day washout period was provided at the beginning of the study to establish an appropriate methamphetamine free condition for safe administration of the second test compound condition. <br/> <b>Days 3-4:</b> On days 3 and 4, given medical stability, participants were then switched to the opposite test compound (atomoxetine 0 or 40mg) under double-blind conditions, in the same manner as in Days 9-10 in Phase I. <br/> <b>Days 5-6:</b> Same procedure as in Days 11-12 in Phase I but with opposite medication condition.<br/> <b>Day 7:</b> Same procedure as in Day13 in Phase I but with opposite medication condition.<br/> <b>Day 8:</b> Same procedure as in Day14 in Phase I but with opposite medication condition.<br/> <b>Day 9:</b> Same procedure as in Day14 in Phase I but with opposite medication condition.<br/> </p> <p> For healthy control participants, the study consisted of 30 days or fewer of out-patient testing. Healthy control participants had an extensive screening, including a history and physical exam performed by a study physician, an EKG, and laboratory studies performed to assess for medical or psychiatric conditions. Control participants meeting criteria were invited back to UCLA to undergo cognitive testing, and some participants received fMRI scans. Participants were required to refrain from illicit and prescription drug use for the duration of the study, which was confirmed with urine toxicology and breath alcohol level testing on examination days. Caffeine was restricted on study days for least 2 hours prior to cognitive testing and MRI scans. Participants were permitted to drink their normal daily intake of caffeine, given the caveat above. On study days, cigarette smoking was permitted to match conditions used with methamphetamine users. The incorporation of smoke breaks during the test day assured that acute nicotine withdrawal did not negatively impact performance on cognitive tests or neuroimaging. The following outlines procedures for healthy control participants:</p> <p> For normal controls, participation involved one day of outpatient screening, and one day of baseline cognitive testing and possible MRI scans. After these procedures were completed, participants were randomized to the first test compound (atomoxetine 40mg or placebo), to be taken once daily in the morning for 2 days. It was then increased to twice daily for the next 3 days, followed by a final dose (40mg or placebo) on the sixth day of study medication. Participants were also asked to bring their pill packages to assess compliance with the study medication. Additionally, control participants completed a series of repeated-measures cognitive testing (on placebo or atomoxetine, respectively) and possibly two fMRI sessions (separated by a short break).</p> <p> After at least a four-day washout period, control participants were instructed to start the opposite test compound (atomoxetine 40mg or placebo), again to be taken once daily in the morning for two days, then twice daily for 3 days, reaching the final dose (40mg or placebo) of the second test compound in the morning. Participants were again asked to bring their pill packages to assess compliance and had blood drawn to assess atomoxetine levels. Control participants then completed another series of cognitive testing and fMRI testing sessions. They were subsequently discharged from the study. Normal control participants returned two weeks after completion of both study phases in order to complete assessments to their physical and psychological status following treatment. </p>
| phs001195 | dbGaP
Project description:Intervention name : trifluridine/tipiracil
INN of the intervention : trifluridine/tipiracil
Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met.
Intervention name : bevacizumab
INN of the intervention : bevacizumab
Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15.
Control intervention name : fluorouracil
INN of the control intervention : fluorouracil
Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.
Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium)
INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium)
Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen
Primary outcome(s): efficacy
Overall survival
Study Design: Randomized, open-label, comparative study
| 2611617 | ecrin-mdr-crc
Project description:Interventions: Regorafenib is administered orally once daily for 21 days followed by 7 days rest. The initial dose of regorafenib is 80mg/day, and dose-escalation to 120mg or 160mg/day should be considered every two weeks.
Primary outcome(s): Time to Treatment Failure
Study Design: Single arm Non-randomized
| 2629998 | ecrin-mdr-crc
Project description:PURPOSE: This tumor response pharmacodynamic model aims to describe primary lesion shrinkage in non-small cell lung cancer over time and determine if concentration-based exposure metrics for gemcitabine or that of its metabolites,n2',2'-difluorodeoxyuridine or gemcitabine triphosphate, are better than gemcitabine dose for prediction of individual response. EXPERIMENTAL DESIGN: Gemcitabine was given thrice weekly on days 1 and 8 in combination with carboplatin, which was given only on day 1 of every cycle. Gemcitabine amount in the body and area under the concentration-time curves of plasma gemcitabine, 2',2'-difluorodeoxyuridine, and intracellular gemcitabine triphosphate in white cells were compared to determine which best describes tumor shrinkage over time. Tumor growth kinetics were described using a Gompertz-like model.
RESULTS: The apparent half-life for the effect of gemcitabine was 7.67 weeks. The tumor turnover time constant was 21.8 week.cm. Baseline tumor size and gemcitabine amount in the body to attain 50% of tumor shrinkage were estimated to be 6.66 cm and 10,600 mg. There was no evidence of relapse during treatment.
2024-09-02 | BIOMD0000000234 | BioModels