NCT01344356 · STUDY IN CONTEXT

Stereotactic Body Radiotherapy for Head and Neck Tumors

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

Complete or partial tumor response or stable disease

12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

→

primary · POSTED

Instances of progressive disease

12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

→

primary · POSTED

Number of participants with any adverse event

9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

→

secondary · POSTED

Number of participants who are alive 5 years following treatment.

9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

→

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-head-and-neck-neoplasm
nct id: NCT01344356
trial label: Stereotactic Body Radiotherapy for Head and Neck Tumors
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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0000
source section id
NCT01344356-om-0000
source outcome index
0
endpoint
Local Control Rate
endpoint definition
Complete or partial tumor response or stable disease
time origin
5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.
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-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0001
source section id
NCT01344356-om-0001
source outcome index
1
endpoint
Local Recurrence
endpoint definition
Instances of progressive disease
time origin
5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.
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-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0002
source section id
NCT01344356-om-0002
source outcome index
2
endpoint
Complication Rate
endpoint definition
Number of participants with any adverse event
time origin
5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.
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-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0003
source section id
NCT01344356-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Number of participants who are alive 5 years following treatment.
time origin
5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.
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-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0000
arm key
OG000
arm label
Benign Tumors
regimen
Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0000
arm key
OG001
arm label
Malignant Tumors
regimen
Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0001
arm key
OG000
arm label
Benign Tumors
regimen
Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0001
arm key
OG001
arm label
Malignant Tumors
regimen
Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0002
arm key
OG000
arm label
Benign Tumors
regimen
Benign head and neck tumors will be treated with Stereotactic body radiotherapy stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0002
arm key
OG001
arm label
Unrescectable Malignant Tumors
regimen
Malignant Head and Neck Tumors will be treated with Stereotactic body radiotherapy. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0003
arm key
OG000
arm label
Benign Tumors
regimen
Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
outcome key
om-0003
arm key
OG001
arm label
Malignant Tumors
regimen
Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01344356-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01344356
harm key
EG000
source section id
NCT01344356-ae
event group key
EG000
event group label
Benign Tumors
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
5 years
event definition
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
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-head-and-neck-neoplasm
nct id
NCT01344356
harm key
EG001
source section id
NCT01344356-ae
event group key
EG001
event group label
Malignant Tumors
serious affected
0
serious at risk
8
other affected
5
other at risk
8
frequency threshold
0
collection period
5 years
event definition
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
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