Trial Outcomes & Findings for Surgical Debulking of Pituitary Adenomas (NCT NCT01371643)
NCT ID: NCT01371643
Last Updated: 2016-08-29
Results Overview
Nadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
3 months
Results posted on
2016-08-29
Participant Flow
Participant milestones
| Measure |
Medical Treatment by Octreotide LAR
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
26
|
|
Overall Study
COMPLETED
|
12
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Medical Treatment by Octreotide LAR
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Surgical Debulking of Pituitary Adenomas
Baseline characteristics by cohort
| Measure |
Medical Treatment by Octreotide LAR
n=15 Participants
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
n=26 Participants
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, Not of Hispanic-American Origin
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic-American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic-American Origin
|
10 participants
n=5 Participants
|
21 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Outcome measures
| Measure |
Medical Treatment by Octreotide LAR
n=15 Participants
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
n=26 Participants
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
50 percentage of participants
Interval 29.9 to 70.1
|
PRIMARY outcome
Timeframe: 3 monthsNadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Outcome measures
| Measure |
Medical Treatment by Octreotide LAR
n=15 Participants
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
n=26 Participants
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
Percentage of Responders (All Treatments)
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
76.9 percentage of participants
Interval 56.4 to 91.0
|
SECONDARY outcome
Timeframe: 3 monthsNadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Outcome measures
| Measure |
Medical Treatment by Octreotide LAR
n=15 Participants
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
n=13 Participants
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
Percentage of Responders (Only Including Surgical Failures in Arm 2)
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
53.9 percentage of participants
Interval 25.1 to 80.8
|
Adverse Events
Medical Treatment by Octreotide LAR
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Surgical Debulking Followed by Octreotide LAR
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medical Treatment by Octreotide LAR
n=15 participants at risk
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
n=26 participants at risk
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
General disorders
Hyponatremia with Abdominal Discomfort
|
0.00%
0/15
|
3.8%
1/26
|
Other adverse events
| Measure |
Medical Treatment by Octreotide LAR
n=15 participants at risk
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR
|
Surgical Debulking Followed by Octreotide LAR
n=26 participants at risk
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting/Diarrhea/Bloating/Constipation/GI distress
|
13.3%
2/15 • Number of events 7
|
34.6%
9/26 • Number of events 19
|
|
Nervous system disorders
Headaches
|
6.7%
1/15 • Number of events 1
|
23.1%
6/26 • Number of events 7
|
|
Surgical and medical procedures
Pain at the Injection site
|
0.00%
0/15
|
7.7%
2/26 • Number of events 2
|
|
Ear and labyrinth disorders
Otitis Media
|
6.7%
1/15 • Number of events 1
|
0.00%
0/26
|
|
Nervous system disorders
Seizures (Seizure disorder since childhood)
|
6.7%
1/15 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Dry nose
|
6.7%
1/15 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 3
|
7.7%
2/26 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Respiratory Infections/Cold symptoms/ Cough
|
0.00%
0/15
|
7.7%
2/26 • Number of events 5
|
|
General disorders
Sinus irritation/pressure
|
0.00%
0/15
|
7.7%
2/26 • Number of events 2
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Dizziness
|
0.00%
0/15
|
11.5%
3/26 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleed
|
0.00%
0/15
|
3.8%
1/26 • Number of events 2
|
|
General disorders
Arm Weakness/Numbing
|
0.00%
0/15
|
3.8%
1/26 • Number of events 2
|
|
General disorders
Muscle ache
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
|
Surgical and medical procedures
Planned excision of occipital skin tumor
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/15
|
3.8%
1/26 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place