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Trial record 6 of 46 for:    SIR-Spheres

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (SIRFLOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00724503
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Colorectal Carcinoma
Liver Metastases
Interventions Device: SIR-Spheres yttrium-90 microspheres
Drug: Systemic chemotherapy (FOLFOX)
Enrollment 530
Recruitment Details Between 10 October 2006 and 26 April 2013, 561 patients were screened. 31 screen failures included 2 patients who were randomized twice. 530 patients were randomized in the Intent to treat (ITT) population from 87 centres in Australia, Europe including Belgium, France, Germany, Israel, Italy and Spain, New Zealand and the US.
Pre-assignment Details  
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Period Title: Overall Study
Started 267 263
Completed 57 43
Not Completed 210 220
Reason Not Completed
Lost to Follow-up             4             8
Withdrawal by Subject             11             23
Death             190             182
Adverse Event             1             0
Not otherwise specified             4             7
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone Total
Hide Arm/Group Description A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) Total of all reporting groups
Overall Number of Baseline Participants 267 263 530
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 267 participants 262 participants 529 participants
63
(28 to 81)
63
(23 to 89)
63
(23 to 89)
[1]
Measure Analysis Population Description: Age was unknown for 1 patient as patient withdrew consent and records
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 262 participants 529 participants
Female
85
  31.8%
88
  33.6%
173
  32.7%
Male
182
  68.2%
174
  66.4%
356
  67.3%
[1]
Measure Analysis Population Description: Sex was unknown for 1 patient as patient withdrew consent and records
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 263 participants 530 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
   2.6%
3
   1.1%
10
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   0.7%
8
   3.0%
10
   1.9%
White
248
  92.9%
243
  92.4%
491
  92.6%
More than one race
4
   1.5%
4
   1.5%
8
   1.5%
Unknown or Not Reported
6
   2.2%
5
   1.9%
11
   2.1%
WHO performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
0 Number Analyzed 267 participants 263 participants 530 participants
176 175 351
1 Number Analyzed 267 participants 263 participants 530 participants
90 87 177
Unknown Number Analyzed 267 participants 263 participants 530 participants
1 1 2
[1]
Measure Description:

WHO performance status: (0) Able to carry out all normal activity without restriction

(1) Restricted in physically strenuous activity but ambulatory and able to carry out light work

Primary tumor in situ  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 263 participants 530 participants
No
148
  55.4%
141
  53.6%
289
  54.5%
Yes
119
  44.6%
121
  46.0%
240
  45.3%
Unknown
0
   0.0%
1
   0.4%
1
   0.2%
Extra-hepatic metastases at randomization  
Measure Type: Number
Unit of measure:  Participants
No Number Analyzed 267 participants 263 participants 530 participants
160 159 319
Yes Number Analyzed 267 participants 263 participants 530 participants
107 104 211
Tumor liver involvement %  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 263 participants 530 participants
<=25%
185
  69.3%
192
  73.0%
377
  71.1%
>25%
81
  30.3%
70
  26.6%
151
  28.5%
Unknown
1
   0.4%
1
   0.4%
2
   0.4%
Synchronous metastases  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 263 participants 530 participants
241
  90.3%
233
  88.6%
474
  89.4%
1.Primary Outcome
Title Progression-Free Survival (PFS) at Any Site
Hide Description PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description:
A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Overall Number of Participants Analyzed 267 263
Median (95% Confidence Interval)
Unit of Measure: Months
10.7
(9.9 to 11.4)
10.2
(9.4 to 11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection mFOLFOX6 Plus SIRT, mFOLFOX6 Alone
Comments The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.551
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Overall Response
Hide Description Tumour Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR) - Disappearance of all target lesions which is confirmed if determined by two observations not less than 4 weeks apart; Partial Response (PR) - >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Through study completion, up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title B: FOLFOX + SIR-Spheres A: FOLFOX Alone
Hide Arm/Group Description:

A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)

SIR-Spheres yttrium-90 microspheres: SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle

Systemic chemotherapy (FOLFOX): Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles

Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards

Leucovorin 200 mg/m2, IV infusion, q two weeks

5-Fluorouracil 400 mg/m2, IV bolus, q two weeks

5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)

Systemic chemotherapy (FOLFOX): Oxaliplatin 85 mg/m2, IV infusion, q two weeks

Leucovorin 200 mg/m2, IV infusion, q two weeks

5-Fluorouracil 400 mg/m2, IV bolus, q two weeks

5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

Overall Number of Participants Analyzed 267 263
Measure Type: Number
Unit of Measure: percentage of participants
76.4 68.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: FOLFOX + SIR-Spheres, A: FOLFOX Alone
Comments A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Estimation Comments [Not Specified]
Time Frame From consent until 28 days post last dose of protocol chemotherapy.
Adverse Event Reporting Description

Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment.

Of the 267 in ‘mFOLFOX6 Plus SIRT’ arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants.

The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.

 
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
All-Cause Mortality
mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   190/246 (77.24%)   182/270 (67.41%) 
Show Serious Adverse Events Hide Serious Adverse Events
mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   134/246 (54.47%)   112/270 (41.48%) 
Blood and lymphatic system disorders     
Anaemia  1  1/246 (0.41%)  4/270 (1.48%) 
Febrile Neutropenia  1  13/246 (5.28%)  4/270 (1.48%) 
Heparin-Induced Thrombocytopenia  1  0/246 (0.00%)  1/270 (0.37%) 
Neutropenia  1  3/246 (1.22%)  2/270 (0.74%) 
Splenic Infarction  1  0/246 (0.00%)  1/270 (0.37%) 
Thrombocytopenia  1  1/246 (0.41%)  1/270 (0.37%) 
Cardiac disorders     
Acute Coronary Syndrome  1  1/246 (0.41%)  0/270 (0.00%) 
Acute Myocardial Infarction  1  2/246 (0.81%)  2/270 (0.74%) 
Angina Pectoris  1  1/246 (0.41%)  1/270 (0.37%) 
Arrhythmia  1  0/246 (0.00%)  1/270 (0.37%) 
Arteriospasm Coronary  1  1/246 (0.41%)  0/270 (0.00%) 
Atrial Fibrillation  1  1/246 (0.41%)  0/270 (0.00%) 
Atrial Flutter  1  1/246 (0.41%)  0/270 (0.00%) 
Atrioventricular Block Complete  1  0/246 (0.00%)  1/270 (0.37%) 
Cardiac Arrest  1  0/246 (0.00%)  1/270 (0.37%) 
Cardiac Failure  1  1/246 (0.41%)  1/270 (0.37%) 
Intracardiac Thrombus  1  1/246 (0.41%)  0/270 (0.00%) 
Myocardial Infarction  1  1/246 (0.41%)  0/270 (0.00%) 
Stress Cardiomyopathy  1  0/246 (0.00%)  1/270 (0.37%) 
Supraventricular Tachycardia  1  0/246 (0.00%)  1/270 (0.37%) 
Congenital, familial and genetic disorders     
Hydrocele  1  1/246 (0.41%)  0/270 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/246 (0.00%)  1/270 (0.37%) 
Gastrointestinal disorders     
Abdominal Pain  1  11/246 (4.47%)  5/270 (1.85%) 
Abdominal Pain Upper  1  4/246 (1.63%)  1/270 (0.37%) 
Anal Fissure  1  0/246 (0.00%)  2/270 (0.74%) 
Anal Inflammation  1  0/246 (0.00%)  1/270 (0.37%) 
Ascites  1  4/246 (1.63%)  0/270 (0.00%) 
Constipation  1  10/246 (4.07%)  7/270 (2.59%) 
Diarrhoea  1  11/246 (4.47%)  8/270 (2.96%) 
Duodenal Ulcer  1  3/246 (1.22%)  1/270 (0.37%) 
Duodenal Ulcer Haemorrhage  1  0/246 (0.00%)  1/270 (0.37%) 
Duodenitis  1  2/246 (0.81%)  0/270 (0.00%) 
Erosive Oesophagitis  1  1/246 (0.41%)  0/270 (0.00%) 
Gastric Haemorrhage  1  1/246 (0.41%)  0/270 (0.00%) 
Gastric Ulcer  1  6/246 (2.44%)  0/270 (0.00%) 
Gastritis  1  4/246 (1.63%)  0/270 (0.00%) 
Gastritis Atrophic  1  1/246 (0.41%)  0/270 (0.00%) 
Gastritis Erosive  1  0/246 (0.00%)  1/270 (0.37%) 
Gastroduodenitis  1  1/246 (0.41%)  0/270 (0.00%) 
Gastrointestinal Haemorrhage  1  5/246 (2.03%)  1/270 (0.37%) 
Haematemesis  1  2/246 (0.81%)  0/270 (0.00%) 
Haemorrhoidal Haemorrhage  1  0/246 (0.00%)  1/270 (0.37%) 
Haemorrhoids  1  0/246 (0.00%)  1/270 (0.37%) 
Ileus  1  0/246 (0.00%)  1/270 (0.37%) 
Intestinal Haematoma  1  0/246 (0.00%)  1/270 (0.37%) 
Intestinal Obstruction  1  4/246 (1.63%)  6/270 (2.22%) 
Intestinal Perforation  1  2/246 (0.81%)  3/270 (1.11%) 
Large Intestinal Obstruction  1  2/246 (0.81%)  2/270 (0.74%) 
Large Intestinal Stenosis  1  1/246 (0.41%)  0/270 (0.00%) 
Large Intestine Perforation  1  1/246 (0.41%)  1/270 (0.37%) 
Melaena  1  1/246 (0.41%)  1/270 (0.37%) 
Nausea  1  8/246 (3.25%)  4/270 (1.48%) 
Oesophageal Ulcer  1  1/246 (0.41%)  0/270 (0.00%) 
Oesophageal Varices Haemorrhage  1  1/246 (0.41%)  1/270 (0.37%) 
Oesophagitis  1  1/246 (0.41%)  0/270 (0.00%) 
Oesophagitis Haemorrhagic  1  0/246 (0.00%)  1/270 (0.37%) 
Oral Pain  1  0/246 (0.00%)  1/270 (0.37%) 
Pancreatitis  1  3/246 (1.22%)  0/270 (0.00%) 
Proctalgia  1  1/246 (0.41%)  1/270 (0.37%) 
Rectal Haemorrhage  1  3/246 (1.22%)  2/270 (0.74%) 
Rectal Stenosis  1  0/246 (0.00%)  1/270 (0.37%) 
Small Intestinal Obstruction  1  1/246 (0.41%)  0/270 (0.00%) 
Stomatitis  1  3/246 (1.22%)  0/270 (0.00%) 
Volvulus Of Small Bowel  1  0/246 (0.00%)  1/270 (0.37%) 
Vomiting  1  16/246 (6.50%)  3/270 (1.11%) 
General disorders     
Asthenia  1  3/246 (1.22%)  1/270 (0.37%) 
Chest Pain  1  3/246 (1.22%)  0/270 (0.00%) 
Chills  1  1/246 (0.41%)  0/270 (0.00%) 
Device Dislocation  1  0/246 (0.00%)  1/270 (0.37%) 
Device Occlusion  1  0/246 (0.00%)  2/270 (0.74%) 
Extravasation  1  0/246 (0.00%)  1/270 (0.37%) 
Fatigue  1  4/246 (1.63%)  0/270 (0.00%) 
General Physical Health Deterioration  1  1/246 (0.41%)  2/270 (0.74%) 
Hernia  1  1/246 (0.41%)  0/270 (0.00%) 
Influenza Like Illness  1  1/246 (0.41%)  0/270 (0.00%) 
Infusion Site Pain  1  0/246 (0.00%)  1/270 (0.37%) 
Malaise  1  1/246 (0.41%)  0/270 (0.00%) 
Oedema Peripheral  1  1/246 (0.41%)  0/270 (0.00%) 
Pain  1  1/246 (0.41%)  0/270 (0.00%) 
Pyrexia  1  17/246 (6.91%)  12/270 (4.44%) 
Hepatobiliary disorders     
Bile Duct Obstruction  1  0/246 (0.00%)  1/270 (0.37%) 
Bile Duct Stone  1  0/246 (0.00%)  1/270 (0.37%) 
Cholangitis  1  2/246 (0.81%)  1/270 (0.37%) 
Cholecystitis  1  1/246 (0.41%)  2/270 (0.74%) 
Cholecystitis Acute  1  1/246 (0.41%)  0/270 (0.00%) 
Cholelithiasis  1  0/246 (0.00%)  1/270 (0.37%) 
Gallbladder Perforation  1  1/246 (0.41%)  0/270 (0.00%) 
Hepatic Failure  1  3/246 (1.22%)  0/270 (0.00%) 
Hepatic Fibrosis  1  1/246 (0.41%)  0/270 (0.00%) 
Hepatic Infarction  1  1/246 (0.41%)  0/270 (0.00%) 
Hepatic Pain  1  0/246 (0.00%)  1/270 (0.37%) 
Hyperbilirubinaemia  1  1/246 (0.41%)  1/270 (0.37%) 
Jaundice  1  1/246 (0.41%)  1/270 (0.37%) 
Jaundice Cholestatic  1  2/246 (0.81%)  1/270 (0.37%) 
Immune system disorders     
Drug Hypersensitivity  1  1/246 (0.41%)  1/270 (0.37%) 
Infections and infestations     
Abdominal Wall Infection  1  1/246 (0.41%)  0/270 (0.00%) 
Abscess Limb  1  1/246 (0.41%)  1/270 (0.37%) 
Acute Sinusitis  1  0/246 (0.00%)  1/270 (0.37%) 
Anorectal Infection  1  1/246 (0.41%)  0/270 (0.00%) 
Campylobacter Gastroenteritis  1  0/246 (0.00%)  1/270 (0.37%) 
Catheter Site Infection  1  0/246 (0.00%)  1/270 (0.37%) 
Device Related Infection  1  2/246 (0.81%)  0/270 (0.00%) 
Diverticulitis  1  0/246 (0.00%)  1/270 (0.37%) 
Escherichia Bacteraemia  1  1/246 (0.41%)  0/270 (0.00%) 
Gastroenteritis  1  5/246 (2.03%)  0/270 (0.00%) 
Gastroenteritis Salmonella  1  1/246 (0.41%)  0/270 (0.00%) 
Infection  1  2/246 (0.81%)  1/270 (0.37%) 
Influenza  1  0/246 (0.00%)  1/270 (0.37%) 
Infusion Site Infection  1  1/246 (0.41%)  2/270 (0.74%) 
Klebsiella Sepsis  1  0/246 (0.00%)  1/270 (0.37%) 
Liver Abscess  1  2/246 (0.81%)  0/270 (0.00%) 
Lobar Pneumonia  1  1/246 (0.41%)  0/270 (0.00%) 
Lower Respiratory Tract Infection  1  1/246 (0.41%)  0/270 (0.00%) 
Lung Infection  1  1/246 (0.41%)  0/270 (0.00%) 
Neutropenic Infection  1  2/246 (0.81%)  2/270 (0.74%) 
Neutropenic Sepsis  1  1/246 (0.41%)  1/270 (0.37%) 
Oesophageal Candidiasis  1  1/246 (0.41%)  0/270 (0.00%) 
Pelvic Abscess  1  0/246 (0.00%)  1/270 (0.37%) 
Perihepatic Abscess  1  2/246 (0.81%)  0/270 (0.00%) 
Peritonitis  1  3/246 (1.22%)  0/270 (0.00%) 
Pneumonia  1  3/246 (1.22%)  4/270 (1.48%) 
Salmonellosis  1  0/246 (0.00%)  1/270 (0.37%) 
Sepsis  1  1/246 (0.41%)  3/270 (1.11%) 
Subcutaneous Abscess  1  1/246 (0.41%)  0/270 (0.00%) 
Upper Respiratory Tract Infection  1  1/246 (0.41%)  2/270 (0.74%) 
Urinary Tract Infection  1  0/246 (0.00%)  1/270 (0.37%) 
Wound Infection  1  1/246 (0.41%)  0/270 (0.00%) 
Injury, poisoning and procedural complications     
Anastomotic Complication  1  0/246 (0.00%)  1/270 (0.37%) 
Anastomotic Leak  1  0/246 (0.00%)  1/270 (0.37%) 
Contrast Media Reaction  1  0/246 (0.00%)  1/270 (0.37%) 
Fall  1  1/246 (0.41%)  2/270 (0.74%) 
Femoral Neck Fracture  1  1/246 (0.41%)  0/270 (0.00%) 
Gastroenteritis Radiation  1  1/246 (0.41%)  1/270 (0.37%) 
Hip Fracture  1  1/246 (0.41%)  0/270 (0.00%) 
Pelvic Fracture  1  1/246 (0.41%)  0/270 (0.00%) 
Post Embolisation Syndrome  1  2/246 (0.81%)  0/270 (0.00%) 
Post Procedural Bile Leak  1  2/246 (0.81%)  0/270 (0.00%) 
Post Procedural Complication  1  0/246 (0.00%)  1/270 (0.37%) 
Post Procedural Diarrhoea  1  0/246 (0.00%)  1/270 (0.37%) 
Procedural Complication  1  1/246 (0.41%)  0/270 (0.00%) 
Procedural Pain  1  2/246 (0.81%)  0/270 (0.00%) 
Radiation Hepatitis  1  2/246 (0.81%)  0/270 (0.00%) 
Rib Fracture  1  0/246 (0.00%)  1/270 (0.37%) 
Spinal Fracture  1  0/246 (0.00%)  1/270 (0.37%) 
Subdural Haematoma  1  0/246 (0.00%)  1/270 (0.37%) 
Toxicity To Various Agents  1  0/246 (0.00%)  1/270 (0.37%) 
Vascular Procedure Complication  1  1/246 (0.41%)  0/270 (0.00%) 
Wound Evisceration  1  0/246 (0.00%)  1/270 (0.37%) 
Investigations     
Alanine Aminotransferase Increased  1  1/246 (0.41%)  0/270 (0.00%) 
Aspartate Aminotransferase Increased  1  1/246 (0.41%)  0/270 (0.00%) 
Blood Albumin Decreased  1  1/246 (0.41%)  0/270 (0.00%) 
Blood Alkaline Phosphatase Increased  1  1/246 (0.41%)  0/270 (0.00%) 
Blood Bilirubin Increased  1  3/246 (1.22%)  0/270 (0.00%) 
Haemoglobin Decreased  1  1/246 (0.41%)  0/270 (0.00%) 
Neutrophil Count Decreased  1  1/246 (0.41%)  1/270 (0.37%) 
Troponin I Increased  1  1/246 (0.41%)  0/270 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  2/246 (0.81%)  2/270 (0.74%) 
Dehydration  1  4/246 (1.63%)  4/270 (1.48%) 
Diabetes Mellitus  1  1/246 (0.41%)  1/270 (0.37%) 
Diabetic Ketoacidosis  1  0/246 (0.00%)  1/270 (0.37%) 
Hyperglycaemia  1  0/246 (0.00%)  2/270 (0.74%) 
Hypoglycaemi  1  1/246 (0.41%)  0/270 (0.00%) 
Hypokalaemia  1  1/246 (0.41%)  0/270 (0.00%) 
Hyponatraemia  1  2/246 (0.81%)  0/270 (0.00%) 
Hypovolaemia  1  1/246 (0.41%)  0/270 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Pain  1  0/246 (0.00%)  1/270 (0.37%) 
Neck Pain  1  1/246 (0.41%)  0/270 (0.00%) 
Pain In Extremity  1  1/246 (0.41%)  0/270 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer  1  0/246 (0.00%)  1/270 (0.37%) 
Colon Neoplasm  1  0/246 (0.00%)  1/270 (0.37%) 
Malignant Ascites  1  1/246 (0.41%)  0/270 (0.00%) 
Metastatic Pain  1  0/246 (0.00%)  1/270 (0.37%) 
Thyroid Cancer  1  1/246 (0.41%)  0/270 (0.00%) 
Nervous system disorders     
Balance Disorder  1  0/246 (0.00%)  1/270 (0.37%) 
Cerebral Haemorrhage  1  0/246 (0.00%)  1/270 (0.37%) 
Cerebral Infarction  1  1/246 (0.41%)  1/270 (0.37%) 
Cerebrovascular Accident  1  3/246 (1.22%)  1/270 (0.37%) 
Dizziness  1  1/246 (0.41%)  0/270 (0.00%) 
Headache  1  2/246 (0.81%)  0/270 (0.00%) 
Hepatic Encephalopathy  1  1/246 (0.41%)  0/270 (0.00%) 
Ischaemic Stroke  1  1/246 (0.41%)  0/270 (0.00%) 
Loss Of Consciousness  1  0/246 (0.00%)  1/270 (0.37%) 
Presyncope  1  1/246 (0.41%)  0/270 (0.00%) 
Syncope  1  1/246 (0.41%)  2/270 (0.74%) 
Transient Ischaemic Attack  1  0/246 (0.00%)  1/270 (0.37%) 
Psychiatric disorders     
Confusional State  1  1/246 (0.41%)  4/270 (1.48%) 
Hallucination  1  0/246 (0.00%)  1/270 (0.37%) 
Mental Status Changes  1  1/246 (0.41%)  0/270 (0.00%) 
Renal and urinary disorders     
Oliguria  1  1/246 (0.41%)  0/270 (0.00%) 
Renal Failure Acute  1  3/246 (1.22%)  1/270 (0.37%) 
Renal Impairment  1  1/246 (0.41%)  0/270 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome  1  0/246 (0.00%)  1/270 (0.37%) 
Chronic Obstructive Pulmonary Disease  1  1/246 (0.41%)  0/270 (0.00%) 
Dyspnea  1  1/246 (0.41%)  0/270 (0.00%) 
Dyspnoea  1  2/246 (0.81%)  3/270 (1.11%) 
Epistaxis  1  2/246 (0.81%)  2/270 (0.74%) 
Hiccups  1  0/246 (0.00%)  1/270 (0.37%) 
Laryngeal Dyspnoea  1  0/246 (0.00%)  1/270 (0.37%) 
Pneumonitis  1  0/246 (0.00%)  2/270 (0.74%) 
Pulmonary embolism  1  11/246 (4.47%)  6/270 (2.22%) 
Respiratory Failure  1  2/246 (0.81%)  0/270 (0.00%) 
Respiratory Tract Haemorrhage  1  1/246 (0.41%)  0/270 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  0/246 (0.00%)  1/270 (0.37%) 
Social circumstances     
Physical Assault  1  1/246 (0.41%)  0/270 (0.00%) 
Social Stay Hospitalisation  1  1/246 (0.41%)  0/270 (0.00%) 
Surgical and medical procedures     
Abscess Drainage  1  0/246 (0.00%)  1/270 (0.37%) 
Gastrointestinal Surgery  1  1/246 (0.41%)  0/270 (0.00%) 
Hernia Repair  1  1/246 (0.41%)  0/270 (0.00%) 
Surgery NOS  1 [1]  1/246 (0.41%)  0/270 (0.00%) 
Vascular disorders     
Artery Dissection  1  1/246 (0.41%)  1/270 (0.37%) 
Circulatory Collapse  1  0/246 (0.00%)  1/270 (0.37%) 
Deep Vein Thrombosis  1  3/246 (1.22%)  2/270 (0.74%) 
Embolism  1  1/246 (0.41%)  0/270 (0.00%) 
Femoral Artery Occlusion  1  0/246 (0.00%)  1/270 (0.37%) 
Haematoma  1  2/246 (0.81%)  1/270 (0.37%) 
Hypertension  1  4/246 (1.63%)  0/270 (0.00%) 
Hypotension  1  3/246 (1.22%)  2/270 (0.74%) 
Hypovolaemic Shock  1  0/246 (0.00%)  1/270 (0.37%) 
Ischaemia  1  0/246 (0.00%)  1/270 (0.37%) 
Orthostatic Hypotension  1  0/246 (0.00%)  1/270 (0.37%) 
Peripheral Artery Stenosis  1  0/246 (0.00%)  1/270 (0.37%) 
Peripheral Artery Thrombosis  1  1/246 (0.41%)  0/270 (0.00%) 
Peripheral Embolism  1  0/246 (0.00%)  1/270 (0.37%) 
Phlebitis  1  1/246 (0.41%)  0/270 (0.00%) 
Thrombosis  1  0/246 (0.00%)  2/270 (0.74%) 
Venous Thrombosis Limb  1  1/246 (0.41%)  0/270 (0.00%) 
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
[1]
NOS: Not Otherwise Specified
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   112/246 (45.53%)   157/270 (58.15%) 
Blood and lymphatic system disorders     
Anaemia  1  29/246 (11.79%)  38/270 (14.07%) 
Febrile Neutropenia  1  15/246 (6.10%)  5/270 (1.85%) 
Leukopenia  1  33/246 (13.41%)  21/270 (7.78%) 
Lymphopenia  1  15/246 (6.10%)  5/270 (1.85%) 
Neutropenia  1  66/246 (26.83%)  102/270 (37.78%) 
Thrombocytopenia  1  97/246 (39.43%)  47/270 (17.41%) 
Gastrointestinal disorders     
Abdominal Pain  1  103/246 (41.87%)  53/270 (19.63%) 
Abdominal Pain Upper  1  77/246 (31.30%)  22/270 (8.15%) 
Ascites  1  23/246 (9.35%)  4/270 (1.48%) 
Constipation  1  108/246 (43.90%)  91/270 (33.70%) 
Diarrhoea  1  103/246 (41.87%)  132/270 (48.89%) 
Dyspepsia  1  25/246 (10.16%)  22/270 (8.15%) 
Gastrooesophageal Reflux Disease  1  18/246 (7.32%)  25/270 (9.26%) 
Nausea  1  15/246 (6.10%)  137/270 (50.74%) 
Rectal Haemorrhage  1  23/246 (9.35%)  18/270 (6.67%) 
Stomatitis  1  45/246 (18.29%)  47/270 (17.41%) 
Vomiting  1  95/246 (38.62%)  74/270 (27.41%) 
General disorders     
Asthenia  1  39/246 (15.85%)  27/270 (10.00%) 
Chest Pain  1  23/246 (9.35%)  10/270 (3.70%) 
Fatigue  1  26/246 (10.57%)  134/270 (49.63%) 
Mucosal Inflammation  1  40/246 (16.26%)  54/270 (20.00%) 
Oedema Peripheral  1  35/246 (14.23%)  17/270 (6.30%) 
Pyrexia  1  57/246 (23.17%)  43/270 (15.93%) 
Immune system disorders     
Drug Hypersensitivity  1  13/246 (5.28%)  7/270 (2.59%) 
Infections and infestations     
Upper Respiratory Tract Infection  1  15/246 (6.10%)  24/270 (8.89%) 
Urinary Tract Infection  1  19/246 (7.72%)  15/270 (5.56%) 
Injury, poisoning and procedural complications     
Procedural Pain  1  32/246 (13.01%)  4/270 (1.48%) 
Blood Alkaline Phosphatase Increased  1  13/246 (5.28%)  8/270 (2.96%) 
Investigations     
Aspartate Aminotransferase Increased  1  13/246 (5.28%)  7/270 (2.59%) 
Neutrophil Count Decreased  1  25/246 (10.16%)  12/270 (4.44%) 
Platelet Count Decreased  1  25/246 (10.16%)  10/270 (3.70%) 
Weight Decreased  1  55/246 (22.36%)  39/270 (14.44%) 
Weight Increased  1  15/246 (6.10%)  21/270 (7.78%) 
White Blood Cell Count Decreased  1  15/246 (6.10%)  4/270 (1.48%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  77/246 (31.30%)  77/270 (28.52%) 
Dehydration  1  14/246 (5.69%)  12/270 (4.44%) 
Hyperglycaemia  1  10/246 (4.07%)  16/270 (5.93%) 
Hypokalaemia  1  23/246 (9.35%)  15/270 (5.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  16/246 (6.50%)  12/270 (4.44%) 
Back Pain  1  32/246 (13.01%)  22/270 (8.15%) 
Musculoskeletal Pain  1  21/246 (8.54%)  16/270 (5.93%) 
Pain In Extremity  1  16/246 (6.50%)  14/270 (5.19%) 
Nervous system disorders     
Dizziness  1  25/246 (10.16%)  29/270 (10.74%) 
Dysgeusia  1  56/246 (22.76%)  52/270 (19.26%) 
Headache  1  35/246 (14.23%)  28/270 (10.37%) 
Lethargy  1  13/246 (5.28%)  13/270 (4.81%) 
Neuropathy Peripheral  1  12/246 (4.88%)  15/270 (5.56%) 
Paraesthesia  1  32/246 (13.01%)  47/270 (17.41%) 
Peripheral Sensory Neuropathy  1  41/246 (16.67%)  43/270 (15.93%) 
Polyneuropathy  1  13/246 (5.28%)  17/270 (6.30%) 
Psychiatric disorders     
Anxiety  1  9/246 (3.66%)  15/270 (5.56%) 
Depression  1  15/246 (6.10%)  8/270 (2.96%) 
Insomnia  1  35/246 (14.23%)  36/270 (13.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  32/246 (13.01%)  34/270 (12.59%) 
Dyspnoea  1  23/246 (9.35%)  30/270 (11.11%) 
Epistaxis  1  61/246 (24.80%)  68/270 (25.19%) 
Hiccups  1  13/246 (5.28%)  15/270 (5.56%) 
Oropharyngeal Pain  1  14/246 (5.69%)  13/270 (4.81%) 
Pulmonary Embolism  1  18/246 (7.32%)  15/270 (5.56%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  29/246 (11.79%)  31/270 (11.48%) 
Dry Skin  1  20/246 (8.13%)  19/270 (7.04%) 
Palmar-Plantar Erythrodysaesthesia  1  21/246 (8.54%)  27/270 (10.00%) 
Rash  1  32/246 (13.01%)  35/270 (12.96%) 
Vascular disorders     
Hypertension  1  42/246 (17.07%)  48/270 (17.78%) 
Hypotension  1  13/246 (5.28%)  14/270 (5.19%) 
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janet Bell, M.B.A.
Organization: Sirtex Medical
Phone: + 888-474-7839 ext 710
EMail: jbell@sirtex.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT00724503     History of Changes
Other Study ID Numbers: STX0206
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: November 7, 2018
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019