NCT01371643 · STUDY IN CONTEXT

Surgical Debulking of Pituitary Adenomas

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

→

primary · POSTED

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.

Source null

→

secondary · POSTED

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.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-adenoma
nct id: NCT01371643
trial label: Surgical Debulking of Pituitary Adenomas
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0000
source section id
NCT01371643-om-0000
source outcome index
0
endpoint
Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
endpoint definition
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.
time origin
3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0001
source section id
NCT01371643-om-0001
source outcome index
1
endpoint
Percentage of Responders (All Treatments)
endpoint definition
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.
time origin
3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0002
source section id
NCT01371643-om-0002
source outcome index
2
endpoint
Percentage of Responders (Only Including Surgical Failures in Arm 2)
endpoint definition
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.
time origin
3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0000
arm key
OG000
arm label
Medical Treatment by Octreotide LAR
regimen
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01371643-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0000
arm key
OG001
arm label
Surgical Debulking Followed by Octreotide LAR
regimen
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01371643-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0001
arm key
OG000
arm label
Medical Treatment by Octreotide LAR
regimen
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01371643-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0001
arm key
OG001
arm label
Surgical Debulking Followed by Octreotide LAR
regimen
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01371643-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0002
arm key
OG000
arm label
Medical Treatment by Octreotide LAR
regimen
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01371643-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
outcome key
om-0002
arm key
OG001
arm label
Surgical Debulking Followed by Octreotide LAR
regimen
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01371643-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
harm key
EG000
source section id
NCT01371643-ae
event group key
EG000
event group label
Medical Treatment by Octreotide LAR
serious affected
0
serious at risk
15
other affected
5
other at risk
15
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT01371643
harm key
EG001
source section id
NCT01371643-ae
event group key
EG001
event group label
Surgical Debulking Followed by Octreotide LAR
serious affected
1
serious at risk
26
other affected
12
other at risk
26
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice