Browse
Submit Data
Databases
API
Help

Dataset Information

33 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Compare two treatment regimens to find out whether one of them FOLFIRI is better than the other Irinotecan alone when combined with Arsenic trioxide

ABSTRACT: Intervention1: modified FOLFIRI plus Arsenic trioxide: Irinotecan 180mg per m2 IV over 90 mins on Day 1 Leucovorin 300mg per m2 IV over 2 hours on Day 1 5 FU - 2400mg per m2 IV over 46 hours continuous infusion starting on Day 1 Arsenic Trioxide 0.15mg per kg IV in 250 ml NS over two hours 1st dose on Days 1 and 2 1 cycle, administered every 2 weeks Start of next IV cycle on D 15 If ATO is well tolerated during the first infusion, then it can be infused over 1 hour from the second dose onwards. Control Intervention1: Irinotecan monotherapy: Irinotecan 180 mg per m2 IV over 90 mins on Day 1 1 cycle, administered every 2 weeks Start of next IV cycle on D 15 The patient will be on supportive care and reviewed with imaging and serologically on a periodic basis, every 3 months + or -15 days as per study or on an SOS basis in case of symptomatic disease worsening Primary outcome(s): Progression free survivalTimepoint: 5 years Study Design: Other Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label

DISEASE(S): Malignant Neoplasm Of Rectum

PROVIDER: 2738867 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

To study how safe and effective is Irinotecanin treatment of colorectal cancer patients.

Project description:Intervention1: Irinotecan injection: ?Irinotecan injection 180 mg/m2 IV over 90 min, on Day 1, Day 15, Day 29 of each cycle. Combination Drug: ?Leucovorin 200 mg/m2 IV over 2 hrs, on Day 1, Day 2, Day 15, Day 16, Day 29, and Day30 of each cycle. ?5-Fluoro Uracil bolus 400 mg/m2 IV bolus, on Day 1, Day 2, Day 15, Day 16, Day 29, and Day 30 of each cycle. ?5-Fluoro Uracil infusion 600 mg/m2 IV over 22 hrs, on Day1, Day 2, Day 15, Day 16, Day29, and Day 30 of each cycle. Control Intervention1: NIL: NIL Primary outcome(s): Overall Objective Response Rate (ORR) by RECIST criteria version 1.1Timepoint: Measured at baseline, before initiation of 3rd cycle (Day85), at the end of 6th cycle (Day240) and if required at the end of the study (1 year)

| 2572851 | ecrin-mdr-crc

Benefits of a combination of chemotherapy tablets and injectable targeted therapy versus using a targeted therapy tablet alone in colorectal cancer patients

Project description:Intervention1: Arm A TAS-102 plus Bevacizumab: Bevacizumab 5 mg per m2 IV over 60 mins q every 15 days subsequent administrations over 30 mins if the initial administration tolerated well plus Tab TAS 102 35 mg per m2 twice daily on days 1to5 and 8 to 12 PO every 28 days 1 cycle Start of next cycle on D 29 Control Intervention1: Arm B Regorafenib: Tab Regorafenib 80 mg PO OD 3 weeks on 1 week off q 28 days 1 cycle Regorafenib dosing will be escalated by 40mg every cycle if there is no grade 3 or grade 4 Regorafenib related adverse events in the prior cycle Primary outcome(s): To evaluate the difference in overall survival (OS) at 6 months between TAS102-Bevacizumab combination and Regorafenib. Timepoint: 53 months Study Design: Other Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label

| 57245 | ecrin-mdr-crc

A clinical study to access safety and efficacy of TK-90 or parenteral TK-90 placebo in patients with colorectal cancer scheduled to receive bolus 5-fluorouracil and infused leucovorin.

Project description:Intervention1: Parenteral TK-90: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Control Intervention1: Parenteral TK-90 Placebo: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Placebo Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Primary outcome(s): A) SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment (TK-90) and TK-90 placebo groups. B) Duration of SOM - Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment; number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (= Grade 2) without a subsequent instance of = Grade 3 OM. patients with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days.Timepoint: 48 Hr and 96 hr every week upto week 06 and at week 08 Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded

| 2738765 | ecrin-mdr-crc

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Project description:Interventions: A: Chemotherapy alone (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Primary resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) Primary outcome(s): Overall survival Study Design: Parallel Randomized

| 2623557 | ecrin-mdr-crc

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

Efficacy exploration of 2nd line in advanced colorectal cancer

Project description:Interventions: Drug : Registry study Day 1. Aflibercept + FOLFIRI • aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus) • Leucovorin: 400 mg/m2 IV infusion for over 2 hours • Irinotecan: 150 mg/m2 IV infusion for over 1 hours • 5-FU: 400 mg/m2 IV bolus injection for over 5 minute • 5-FU: 2400 mg/m2IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity 17 potential protein biomarkers, including cytokines and angiogenic factors, is chosen for analysis based on their roles in tumor progression: HGF, PIGF, VEGF-A, VEGF-C, VEGF-D, INF-r, IL-6, IL-8, Angiopoietin-2, sNeuropillin-1, TSP-2, OPN, sVEGFR1,2,3, sICAM-1, sVCAM-1, and TIMP-1 - Plasma is collected at baseline (Cycle 1) and cycle 4 - Plasma levels of the potential biomarkers are determined by enzyme-linked immunosorbent assays Primary outcome(s): Profression free survival

| 2512693 | ecrin-mdr-crc

A Study Of PF-05212384 plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS and NRAS Wild Type Metastatic Colorectal Cancer

Project description:Intervention name : Drug: PF-05212384 Drug: Irinotecan Dosage And administration of the intervention : PF-05212384: 30 minute IV infusion of PF-05212384 110 mg on days 2, 9, 16 and 23 of each cycle Irinotecan: 90 minutes IV infusion of irinotecan 180mg/m2 on days 1 and 15 of each cycle Control intervention name : Drug: Cetuximub Drug: irinotecan Dosage And administration of the control intervention : Cetuximab: 120 minute IV infusion of cetuximab 400 mg/m2 on cycle 1 day 1; 60 minute IV infusion of cetuximab 250 mg/m2 on day 8, 15, and 22 of each cycle and on day of each cycle after cycle 1. Irinotecan: 90 minutes IV infusion of irinotecan 180mg/m2 on days 1 and 15 of each cycle Primary outcome(s): PFS Study Design: Open, 2 arm, randomized controlled trial

| 2611015 | ecrin-mdr-crc

A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer (JCOG1107)

Project description:Interventions: A: Open primary tumor resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m2 as a 2-hour IV on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Laparoscopic primary tumor resection followed by the same chemotherapy as arm A (mFOLFOX6 or CapeOX plus bevacizumab) Primary outcome(s): Progression-free survival Study Design: Parallel Randomized

| 2625109 | ecrin-mdr-crc

Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.

Project description:Interventions: Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox). Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site. Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks. Primary outcome(s): Disease free survival, determined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause.[During treatment: prior to each treatment cycle. Patients on the 3 month treatment arm will be reviewed 4 weekly for the first twelve weeks after completion of chemotherapy. Clinical examination and Carcinoembryonic Antigen test will be performed at each visit. Follow-up: assessment will be at three monthly intervals until month 12 then 6 monthly until month 24 and annually thereafter.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

| 2454988 | ecrin-mdr-crc

Chemotherapy with Camptothecin-11 (CPT-11), Fluorouracil (5FU), folinic acid and oxaliplatin in patients with metastatic colorectal cancer

Project description:Interventions: CPT-11+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: CPT-11: 80 mg/m2 in 250 ml normal saline intravenous injection (IV) over 90 minutes Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus. This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). Then, it will be followed by Oxaliplatin+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: Oxaliplatin: 45 mg/m2 IV over a 90 min infusion Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). The overall duration of the intervention will be 32 weeks in total (4 cycles). Primary outcome(s): Objective Response Rate (ORR). The ORR will be assessed by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc.[At 32 months from study initiation] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

| 2454913 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data