Trial Outcomes & Findings for Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement (NCT NCT00537823)
NCT ID: NCT00537823
Last Updated: 2016-12-20
Results Overview
Fraction of patients with any grade of complication I-V
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
30 days following surgery
Results posted on
2016-12-20
Participant Flow
The study opened to participant enrollment on 06/06/2007 and closed to participants enrollment on 11/03/2009.
Participant milestones
| Measure |
Arm 1 - Wildtype
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Week 7
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Week 7, 15
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm 1 - Wildtype
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Week 7
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Week 7, 15
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
Baseline characteristics by cohort
| Measure |
Arm 1 - Wildtype
n=7 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=2 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Week 7
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
Week 7, 15
* Leucovorin 400 mg/m2 IV
* Oxaliplatin 85 mg/m2 IV
* 5FU bolus 400 mg/m2
* 5FU CIVI 1200 mg/m2
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
62 years
n=4 Participants
|
62 years
n=27 Participants
|
|
Gender
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Gender
Male
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
2 participants
n=4 Participants
|
9 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 30 days following surgeryPopulation: 4 participants did not have surgery.
Fraction of patients with any grade of complication I-V
Outcome measures
| Measure |
Arm 1 - Wildtype
n=4 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=1 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Postoperative Complication Rate
|
25 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 30 days following surgeryPopulation: 4 participants did not have surgery.
Fraction of patients with any complication grades IV and V
Outcome measures
| Measure |
Arm 1 - Wildtype
n=4 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=1 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Major Postoperative Complication Rate
|
25 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 30 days following surgeryPopulation: 4 participants did not have surgery.
Outcome measures
| Measure |
Arm 1 - Wildtype
n=4 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=1 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
All-cause Mortality
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 7 participants were not evaluable. 4 participants did not have surgery (3 in Arm 1, 1 in Arm 2). 1 participant had surgery but was not resectable (Arm 1) . 1 participant developed another primary cancer (Arm 1). 1 participant died before recurrence from hepatic failure (Arm 1).
Liver only vs distant disease
Outcome measures
| Measure |
Arm 1 - Wildtype
n=1 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=1 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Postoperative Recurrence Patterns
Liver only
|
0 participants
|
0 participants
|
|
Postoperative Recurrence Patterns
Distant disease
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Time of surgery (approximately 11-16 weeks)Population: 4 participants did not have surgery.
Outcome measures
| Measure |
Arm 1 - Wildtype
n=4 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=1 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Histologic Hepatic Toxicity at Surgery
Not reported on pathology report
|
1 participants
|
0 participants
|
|
Histologic Hepatic Toxicity at Surgery
Mild
|
1 participants
|
0 participants
|
|
Histologic Hepatic Toxicity at Surgery
Aborted surgery
|
1 participants
|
0 participants
|
|
Histologic Hepatic Toxicity at Surgery
None
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Time of surgery (approximately 11-16 weeks)Population: 4 participants did not have surgery and are not included in this outcome measure. The study pathologist left the university early prior to completion of study pathology for this study.
* NASH Scoring * Steatosis \*\*\<5% = 0 \*\*5-33%=1 \*\*\>33-66%=2 \*\*\>66%=3 * Lobular inflammation \*\*No foci=0 \*\*\<2 foci per x 200 field=1 \*\*2-4 foci per x 200 field=2 \*\*\>4 foci per x 200 field=3 * Hepatocellular ballooning \*\*None=0 \*\*Few balloon cells = 1 \*\*Many cells/prominent ballooning=2
Outcome measures
| Measure |
Arm 1 - Wildtype
n=4 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=1 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Nonalcoholic Steatohepatitis Score (0-3)
Not reported on pathology report
|
3 participants
|
0 participants
|
|
Nonalcoholic Steatohepatitis Score (0-3)
Aborted surgery
|
1 participants
|
0 participants
|
|
Nonalcoholic Steatohepatitis Score (0-3)
Score 0
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Time of surgery (approximately 11-16 weeks)Population: Data was not collected for this outcome measure as the study pathologist left the institution early prior to study closure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Upon completion of neoadjuvant chemotherapy (approximately 2 months)Population: 2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.
Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.
Outcome measures
| Measure |
Arm 1 - Wildtype
n=5 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=2 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Effect of Preoperative Chemotherapy on Tumor Size
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Completion of neoadjuvant therapy (approximately 8 weeks)Population: 2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.
-Compare total longest diameter from baseline to preoperative CT scan.
Outcome measures
| Measure |
Arm 1 - Wildtype
n=5 Participants
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=2 Participants
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Change in Tumor Size From Pretreatment to Preoperative CT Scan
|
-23.8 percentage of change of longest diameter
Interval -71.7 to -0.7
|
-14.3 percentage of change of longest diameter
Interval -28.0 to 2.1
|
Adverse Events
Arm 1 - Wildtype
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 2 K-Ras 12/13 Codon Mutation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - Wildtype
n=7 participants at risk
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=2 participants at risk
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Investigations
Hyperbilirubinemia
|
28.6%
2/7
|
0.00%
0/2
|
|
Infections and infestations
Febrile neutropenia
|
14.3%
1/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7
|
0.00%
0/2
|
|
Vascular disorders
Thrombosis
|
28.6%
2/7
|
0.00%
0/2
|
|
Hepatobiliary disorders
Death NOS
|
14.3%
1/7
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
14.3%
1/7
|
0.00%
0/2
|
Other adverse events
| Measure |
Arm 1 - Wildtype
n=7 participants at risk
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
|
Arm 2 K-Ras 12/13 Codon Mutation
n=2 participants at risk
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
|
|---|---|---|
|
Immune system disorders
Seasonal allergies
|
0.00%
0/7
|
50.0%
1/2
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7
|
50.0%
1/2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
85.7%
6/7
|
100.0%
2/2
|
|
Investigations
Leukocytes
|
100.0%
7/7
|
100.0%
2/2
|
|
Investigations
Lymphopenia
|
85.7%
6/7
|
100.0%
2/2
|
|
Investigations
Neutrophils
|
85.7%
6/7
|
100.0%
2/2
|
|
Investigations
Platelets
|
85.7%
6/7
|
100.0%
2/2
|
|
Investigations
INR
|
42.9%
3/7
|
100.0%
2/2
|
|
Investigations
PTT
|
28.6%
2/7
|
100.0%
2/2
|
|
Investigations
Fatigue
|
85.7%
6/7
|
100.0%
2/2
|
|
Metabolism and nutrition disorders
Anorexia
|
71.4%
5/7
|
100.0%
2/2
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7
|
100.0%
2/2
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7
|
100.0%
2/2
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
4/7
|
100.0%
2/2
|
|
Respiratory, thoracic and mediastinal disorders
Resp-bronchopulmonary hemorrhage
|
0.00%
0/7
|
50.0%
1/2
|
|
Infections and infestations
Infection grade 1/2 normal ANC - general (wound)
|
0.00%
0/7
|
50.0%
1/2
|
|
Infections and infestations
Infection grade 1/2 normal ANC - pulmonary (sinus)
|
0.00%
0/7
|
50.0%
1/2
|
|
Infections and infestations
Infection grade 1/2 normal ANC - pulmonary (up airway)
|
0.00%
0/7
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Albumin, serum-low
|
57.1%
4/7
|
100.0%
2/2
|
|
Investigations
Alkaline phosphatase
|
57.1%
4/7
|
100.0%
2/2
|
|
Investigations
ALT
|
71.4%
5/7
|
100.0%
2/2
|
|
Investigations
AST
|
71.4%
5/7
|
100.0%
2/2
|
|
Investigations
Creatinine
|
0.00%
0/7
|
50.0%
1/2
|
|
Investigations
GGT
|
0.00%
0/7
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
3/7
|
100.0%
2/2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
71.4%
5/7
|
100.0%
2/2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
4/7
|
100.0%
2/2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7
|
50.0%
1/2
|
|
Nervous system disorders
Neuropathy - sensory
|
57.1%
4/7
|
100.0%
2/2
|
|
Gastrointestinal disorders
Pain - GI (Abdomen NOS)
|
0.00%
0/7
|
50.0%
1/2
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pulmonary (Throat)
|
0.00%
0/7
|
50.0%
1/2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7
|
100.0%
2/2
|
|
Renal and urinary disorders
Decreased urination
|
0.00%
0/7
|
50.0%
1/2
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/7
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Pain - Musculoskeletal (Back)
|
28.6%
2/7
|
100.0%
2/2
|
|
Musculoskeletal and connective tissue disorders
Pain - Musculoskeletal (Limb)
|
28.6%
2/7
|
100.0%
2/2
|
|
Nervous system disorders
Pain - Neurology (Headache)
|
0.00%
0/7
|
50.0%
1/2
|
|
Hepatobiliary disorders
Pain - Other (Liver pain)
|
0.00%
0/7
|
50.0%
1/2
|
|
Vascular disorders
Hypotension
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Elevated PT
|
14.3%
1/7
|
0.00%
0/2
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Rigors/chills
|
28.6%
2/7
|
0.00%
0/2
|
|
Investigations
Sweating
|
28.6%
2/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
14.3%
1/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
28.6%
2/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
57.1%
4/7
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot reaction
|
14.3%
1/7
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7
|
0.00%
0/2
|
|
Gastrointestinal disorders
Digestive problems
|
14.3%
1/7
|
0.00%
0/2
|
|
Gastrointestinal disorders
Heartburn
|
14.3%
1/7
|
0.00%
0/2
|
|
Gastrointestinal disorders
Mucositis (oral cavity)
|
28.6%
2/7
|
0.00%
0/2
|
|
Gastrointestinal disorders
Mucositis (stomach)
|
14.3%
1/7
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage (resp-nose)
|
28.6%
2/7
|
0.00%
0/2
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
28.6%
2/7
|
0.00%
0/2
|
|
Infections and infestations
Febrile neutropenia
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Slight puffiness in right upper lip
|
14.3%
1/7
|
0.00%
0/2
|
|
Infections and infestations
Vaginal infection
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Edema: limb
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Bilirubin
|
14.3%
1/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
14.3%
1/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
28.6%
2/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
42.9%
3/7
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.9%
3/7
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - whole body
|
14.3%
1/7
|
0.00%
0/2
|
|
Psychiatric disorders
Depression
|
14.3%
1/7
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7
|
0.00%
0/2
|
|
Nervous system disorders
Neuropathy (motor)
|
14.3%
1/7
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
14.3%
1/7
|
0.00%
0/2
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
14.3%
1/7
|
0.00%
0/2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
14.3%
1/7
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place