Clinical Trial Results:
Intra-hepatic and systemic chemotherapy with or without antibody for patients with non-resectable liver metastasis from solid tumours
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Summary
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EudraCT number |
2011-000273-31 |
Trial protocol |
DK |
Global end of trial date |
31 May 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Sep 2020
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First version publication date |
16 Sep 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AA1023
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01511146 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Herlev University Hospital
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Sponsor organisation address |
Herlev Ringvej 75, Herlev, Denmark, 2730
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Public contact |
Dorte Nielsen, Department of Oncology, +45 38682344, Dorte.nielsen.01@regionh.dk
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Scientific contact |
Dorte Nielsen, Department of Oncology, +45 38682344, Dorte.nielsen.01@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
31 May 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Tumour response (RECIST version 1.1)
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Protection of trial subjects |
Patients with informed consent and fulfilling eligibility criteria were included. Continues monitoring of standard safety parameters during treatment.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Jun 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 70
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Worldwide total number of subjects |
70
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EEA total number of subjects |
70
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
41
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From 65 to 84 years |
29
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients recruited at single site at Herlev Hospital, Department of Oncology, Denmark, Recruitment was open from June 2011 to November 2016 | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Patients with histologically confirmed solid tumor with metastases in liver were allowed. Patients were included if the liver metastases were not eligible for local ablation by RFA, SBRT, or surgery evaluated at a MDT conference and had <70% of the liver affected. | ||||||||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
70 | ||||||||||||||||||||||||
Number of subjects completed |
65 | ||||||||||||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Intrahepatic administration not possible: 2 | ||||||||||||||||||||||||
Reason: Number of subjects |
Adverse event, non-fatal: 3 | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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FOLFOX | ||||||||||||||||||||||||
Arm description |
For patients with colorectal cancer without prior treatment with oxaliplatin: Regimen FOLFOX with alternating systemic and intrahepatic application of oxaliplatin (max 6 intrahepatic applications) Patients with KRAS wildtype tumor additionally received cetuximab | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Oxaliplatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intrahepatic use , Intravenous use
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Dosage and administration details |
85 mg/m² every second week,
application no. 1,3,5,7,9,11 intravenous
application no 2,4,6,8,10,12 intrahepatic
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Investigational medicinal product name |
5-Fluorouracil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
400 mg/m² bolus and 2400 mg/m² over 46 hours, every second week
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Investigational medicinal product name |
Leucovorin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
400 mg/m² every second week
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Investigational medicinal product name |
Cetuximab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
500 mg/m2 every 2 weeks
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Arm title
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CaMiGem | ||||||||||||||||||||||||
Arm description |
For patients with other solid tumors or patients with colorectal cancer, that had received oxaliplatin before Regimen consisting of Capecitabine + intrahepatic application of gemcitabine and mitomycin | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Capecitabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
first three patients recieved capecitabine 500 mg/m2 twice a day continuously, other patients received capecitabine 650 mg/m2 twice a day continuously
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Investigational medicinal product name |
Mitomycin C
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for infusion
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Routes of administration |
Intrahepatic use
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Dosage and administration details |
First three + three patients to receive 5 mg/m2 every 4 weeks, other patients to receive 6 mg/m2 every 4 weeks
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Investigational medicinal product name |
Gemcitabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for infusion
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Routes of administration |
Intrahepatic use
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Dosage and administration details |
All patients to receive 800 mg/m2 every 4 weeks
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: worldwide enrolled number includes 5 patients that signed consent and registered for the trial, but did not complete pre-assignment period |
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Baseline characteristics reporting groups
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Reporting group title |
FOLFOX
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Reporting group description |
For patients with colorectal cancer without prior treatment with oxaliplatin: Regimen FOLFOX with alternating systemic and intrahepatic application of oxaliplatin (max 6 intrahepatic applications) Patients with KRAS wildtype tumor additionally received cetuximab | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
CaMiGem
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Reporting group description |
For patients with other solid tumors or patients with colorectal cancer, that had received oxaliplatin before Regimen consisting of Capecitabine + intrahepatic application of gemcitabine and mitomycin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
FOLFOX
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Reporting group description |
For patients with colorectal cancer without prior treatment with oxaliplatin: Regimen FOLFOX with alternating systemic and intrahepatic application of oxaliplatin (max 6 intrahepatic applications) Patients with KRAS wildtype tumor additionally received cetuximab | ||
Reporting group title |
CaMiGem
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Reporting group description |
For patients with other solid tumors or patients with colorectal cancer, that had received oxaliplatin before Regimen consisting of Capecitabine + intrahepatic application of gemcitabine and mitomycin | ||
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End point title |
Tumor response [1] | ||||||||||||||||||||||||
End point description |
Tumor response evaluation according to RECIST v1.1
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End point type |
Primary
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End point timeframe |
Tumor evaluation was performed at baseline and every 8 weeks during treatment and every 3 months in FU
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This was a phase 2 study with 2 arm investigating 2 different drug combinations. It was not planned to compare these combination. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Progression free Survival | ||||||||||||
End point description |
PFS is defined as the period from the first treatment to the first observation of disease progression or death of any cause, whichever came first, or censored at last follow-up. Median and CI determined using Kaplan-Meier.
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End point type |
Secondary
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End point timeframe |
Tumor evaluation was performed every 8 weeks during treatment and every 3 months in FU,
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Overall Survival | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
OS was calculated as the time from the first treatment to death from any cause or censored at last follow-up.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
No. of patients receiving liver resection/RFA | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Resectability was assessed at time of tumor evaluation during treatment.
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Start of treatment until 30 days after last treatment
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Adverse event reporting additional description |
Apart from Serious adverse events, only adverse events assessed as treatment-related are listed.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NCI-CTCAE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4
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Reporting groups
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Reporting group title |
FOLFOX
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Reporting group description |
For patients with colorectal cancer without prior treatment with oxaliplatin: Regimen FOLFOX with alternating systemic and intrahepatic application of oxaliplatin (max 6 intrahepatic applications) Patients with KRAS wildtype tumor additionally received cetuximab | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
CaMiGem
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Reporting group description |
For patients with other solid tumors or patients with colorectal cancer, that had received oxaliplatin before Regimen consisting of Capecitabine + intrahepatic application of gemcitabine and mitomycin | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Only 45 patient recieved TACE, the additional 5 patient did no complete pre-assignment period |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Total number exposed includes the patient that did not complete pre-assignment period as those are included in reporting of Serious Events, however non-serious event are reported for patient in the treatment period only. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Sep 2011 |
- Option to use permanent intrahepatic cateter omitted
- Patients to receive diary to record pain |
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12 Jan 2012 |
Clarification that maximum of 6 intrahepatic applications of chemotherapy will be given |
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16 Feb 2016 |
Prolongation of recruitment and study timelines |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/30999314 |
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