Trial Outcomes & Findings for Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer (NCT NCT00143403)
NCT ID: NCT00143403
Last Updated: 2010-09-28
Results Overview
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
last tumor assessment date or cut-off date, whichever is earlier.
Results posted on
2010-09-28
Participant Flow
study was conducted at 66 centers.
Eligible subjects (subjects who underwent complete liver metastasis resection within 8 weeks of study drug administration) were randomly assigned. Of the 321 subjects randomized in the study, all but 15 were treated.
Participant milestones
| Measure |
5-FU/FA
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
161
|
|
Overall Study
Treated
|
153
|
153
|
|
Overall Study
COMPLETED
|
125
|
115
|
|
Overall Study
NOT COMPLETED
|
35
|
46
|
Reasons for withdrawal
| Measure |
5-FU/FA
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
8
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
12
|
|
Overall Study
Relapse
|
15
|
7
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
specified by site
|
4
|
9
|
|
Overall Study
Randomized Not Treated
|
7
|
8
|
Baseline Characteristics
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Baseline characteristics by cohort
| Measure |
5-FU/FA
n=153 Participants
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
n=153 Participants
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61 years
n=5 Participants
|
63 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
116.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
190.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: last tumor assessment date or cut-off date, whichever is earlier.Population: Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA \& Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Outcome measures
| Measure |
5-FU/FA
n=153 Participants
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
n=153 Participants
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
|---|---|---|
|
Disease Free Survival (DFS)
|
21.6 months
Interval 14.6 to 30.4
|
24.7 months
Interval 18.7 to 38.9
|
SECONDARY outcome
Timeframe: Median follow-up time (42 months)Population: Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA \& Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).
Probability of being alive was calculated in a yearly increment.
Outcome measures
| Measure |
5-FU/FA
n=153 Participants
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
n=153 Participants
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
|---|---|---|
|
Overall Survival Rates
12 months
|
0.961 survival rate
|
0.973 survival rate
|
|
Overall Survival Rates
24 months
|
0.845 survival rate
|
0.881 survival rate
|
|
Overall Survival Rates
36 months
|
0.716 survival rate
|
0.727 survival rate
|
Adverse Events
5-FU/FA
Serious events: 15 serious events
Other events: 146 other events
Deaths: 0 deaths
Irinotecan + 5-FU/FA
Serious events: 32 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5-FU/FA
n=152 participants at risk
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
n=154 participants at risk
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain NOS
|
1.3%
2/152
|
0.65%
1/154
|
|
Cardiac disorders
Acute coronary syndrome
|
0.66%
1/152
|
0.00%
0/154
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
0.00%
0/152
|
0.65%
1/154
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/152
|
0.65%
1/154
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152
|
0.65%
1/154
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/152
|
0.65%
1/154
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/152
|
0.65%
1/154
|
|
Cardiac disorders
Cardiac disorder NOS
|
0.00%
0/152
|
0.65%
1/154
|
|
General disorders
Catheter related complication
|
0.00%
0/152
|
0.65%
1/154
|
|
Infections and infestations
Catheter related infection
|
0.66%
1/152
|
0.65%
1/154
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/152
|
0.65%
1/154
|
|
General disorders
Chest pain
|
0.00%
0/152
|
1.3%
2/154
|
|
Hepatobiliary disorders
Cholecystitis acute NOS
|
0.00%
0/152
|
0.65%
1/154
|
|
Vascular disorders
Circulatory collapse
|
0.66%
1/152
|
0.00%
0/154
|
|
Gastrointestinal disorders
Constipation
|
0.66%
1/152
|
0.65%
1/154
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
1/152
|
3.2%
5/154
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/152
|
1.3%
2/154
|
|
Psychiatric disorders
Depression
|
0.00%
0/152
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Device failure
|
0.66%
1/152
|
0.00%
0/154
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
0.00%
0/152
|
4.5%
7/154
|
|
Nervous system disorders
Dizziness
|
0.00%
0/152
|
1.9%
3/154
|
|
Gastrointestinal disorders
Enteritis
|
0.66%
1/152
|
0.00%
0/154
|
|
General disorders
Gait abnormal
|
0.00%
0/152
|
0.65%
1/154
|
|
Hepatobiliary disorders
Hepatic disorder NOS
|
0.66%
1/152
|
0.00%
0/154
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.66%
1/152
|
0.00%
0/154
|
|
General disorders
Injection site thrombosis
|
0.00%
0/152
|
0.65%
1/154
|
|
Gastrointestinal disorders
Intestinal obstruction NOS
|
1.3%
2/152
|
0.00%
0/154
|
|
Infections and infestations
Liver abscess
|
0.00%
0/152
|
1.3%
2/154
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/152
|
0.65%
1/154
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/152
|
0.65%
1/154
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/152
|
1.9%
3/154
|
|
Infections and infestations
Neutropenic sepsis
|
0.66%
1/152
|
0.00%
0/154
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.66%
1/152
|
0.00%
0/154
|
|
Musculoskeletal and connective tissue disorders
Peripheral swelling
|
0.00%
0/152
|
0.65%
1/154
|
|
Vascular disorders
Phlebitis NOS
|
0.00%
0/152
|
0.65%
1/154
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
0.00%
0/152
|
1.3%
2/154
|
|
General disorders
Pyrexia
|
0.00%
0/152
|
1.3%
2/154
|
|
Gastrointestinal disorders
Rectovaginal fistula
|
0.00%
0/152
|
0.65%
1/154
|
|
Renal and urinary disorders
Renal impairment NOS
|
0.00%
0/152
|
0.65%
1/154
|
|
Infections and infestations
Septic shock
|
0.00%
0/152
|
0.65%
1/154
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/152
|
0.65%
1/154
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/152
|
0.65%
1/154
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/152
|
0.65%
1/154
|
|
Nervous system disorders
Syncope
|
0.00%
0/152
|
0.65%
1/154
|
|
Cardiac disorders
Tachycardia NOS
|
0.00%
0/152
|
0.65%
1/154
|
|
Vascular disorders
Thrombosis
|
0.66%
1/152
|
0.65%
1/154
|
|
Gastrointestinal disorders
Vomiting NOS
|
1.3%
2/152
|
1.3%
2/154
|
Other adverse events
| Measure |
5-FU/FA
n=152 participants at risk
simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
Irinotecan + 5-FU/FA
n=154 participants at risk
irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.2%
17/152
|
14.3%
22/154
|
|
Gastrointestinal disorders
Abdominal pain, NOS
|
26.3%
40/152
|
26.6%
41/154
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.4%
28/152
|
44.8%
69/154
|
|
Blood and lymphatic system disorders
Anemia NOS
|
12.5%
19/152
|
13.6%
21/154
|
|
Metabolism and nutrition disorders
Anorexia
|
13.8%
21/152
|
20.8%
32/154
|
|
Psychiatric disorders
Anxiety
|
1.3%
2/152
|
5.8%
9/154
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
5.3%
8/152
|
3.9%
6/154
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
7/152
|
6.5%
10/154
|
|
General disorders
Asthenia
|
31.6%
48/152
|
34.4%
53/154
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
10/152
|
6.5%
10/154
|
|
Nervous system disorders
Cholinergic syndrome
|
0.66%
1/152
|
11.0%
17/154
|
|
Eye disorders
Conjunctivitis
|
5.9%
9/152
|
1.3%
2/154
|
|
Gastrointestinal disorders
Constipation
|
19.7%
30/152
|
29.9%
46/154
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
11/152
|
8.4%
13/154
|
|
Gastrointestinal disorders
Diarrhea, NOS
|
52.6%
80/152
|
63.6%
98/154
|
|
Nervous system disorders
Dizziness
|
9.2%
14/152
|
7.8%
12/154
|
|
Nervous system disorders
Dysgeusia
|
12.5%
19/152
|
6.5%
10/154
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
15/152
|
9.1%
14/154
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
5.9%
9/152
|
2.6%
4/154
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
13/152
|
12.3%
19/154
|
|
General disorders
Fatigue
|
18.4%
28/152
|
22.1%
34/154
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
3/152
|
5.2%
8/154
|
|
Nervous system disorders
Headache
|
15.1%
23/152
|
14.3%
22/154
|
|
Psychiatric disorders
Insomnia
|
9.2%
14/152
|
7.1%
11/154
|
|
Eye disorders
Lacrimation increased
|
8.6%
13/152
|
7.8%
12/154
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
6.6%
10/152
|
17.5%
27/154
|
|
General disorders
Mucosal inflammation NOS
|
20.4%
31/152
|
20.8%
32/154
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.6%
10/152
|
5.2%
8/154
|
|
Gastrointestinal disorders
Nausea
|
59.9%
91/152
|
75.3%
116/154
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.4%
25/152
|
40.3%
62/154
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.4%
25/152
|
13.0%
20/154
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.3%
8/152
|
5.2%
8/154
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder NOS
|
8.6%
13/152
|
4.5%
7/154
|
|
General disorders
Pyrexia
|
6.6%
10/152
|
8.4%
13/154
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis NOS
|
7.2%
11/152
|
5.8%
9/154
|
|
Gastrointestinal disorders
Stomatitis
|
26.3%
40/152
|
22.1%
34/154
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
9/152
|
2.6%
4/154
|
|
Gastrointestinal disorders
Vomiting, NOS
|
24.3%
37/152
|
41.6%
64/154
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER