NCT00068237 · STUDY IN CONTEXT

Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

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. 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

Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.

Eligible patients who started study treatment.

→

secondary · POSTED

The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).

Eligible patients who started RT

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secondary · POSTED

Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.

Eligible patients with salivary scans submitted

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secondary · POSTED

The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.

Eligible patients with both baseline and 1-year questionnaire completed

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secondary · POSTED

Facial edema was noted as present or absent following surgery.

Eligible patients who received the procedure

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secondary · POSTED

Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy.

Eligible patients who started RT

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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

Unnamed quality-of-life measure · Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-malignant-head-and-neck-neoplasm
nct id: NCT00068237
qol key: qol-0003
source section id: NCT00068237-om-0003
source outcome index: 3
instrument: Unnamed quality-of-life measure
instrument basis: matched 'health related quality' in the study's own wording
scale title: Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
measure definition: The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.
time frame: Baseline and one year
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Eligible patients with both baseline and 1-year questionnaire completed
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-malignant-head-and-neck-neoplasm
nct id: NCT00068237
trial label: Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
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.
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: 6
harms Count: 1
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0000
source section id
NCT00068237-om-0000
source outcome index
0
endpoint
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
endpoint definition
Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.
time origin
At the time of the submandibular salivary gland transfer
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started study treatment.
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-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0001
source section id
NCT00068237-om-0001
source outcome index
1
endpoint
Percentage of Patients With Acute Xerostomia
endpoint definition
The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).
time origin
From start of treatment to 90 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started RT
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-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0002
source section id
NCT00068237-om-0002
source outcome index
2
endpoint
Percentage of Patients With Normal Functioning Transferred Submandibular Gland
endpoint definition
Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.
time origin
Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with salivary scans submitted
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-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0003
source section id
NCT00068237-om-0003
source outcome index
3
endpoint
Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
endpoint definition
The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.
time origin
Baseline and one year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with both baseline and 1-year questionnaire completed
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-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0004
source section id
NCT00068237-om-0004
source outcome index
4
endpoint
Percentage of Patients Experiencing Facial Edema Following Surgery
endpoint definition
Facial edema was noted as present or absent following surgery.
time origin
From surgery to 30 days after surgery
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who received the procedure
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-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0005
source section id
NCT00068237-om-0005
source outcome index
5
endpoint
Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy
endpoint definition
Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy.
time origin
From start of radiation therapy to 90 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started RT
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-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0000
arm key
OG000
arm label
Surgery + Transfer + Radiation
regimen
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068237-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0001
arm key
OG000
arm label
Surgery + Transfer + Radiation
regimen
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068237-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0002
arm key
OG000
arm label
Surgery + Transfer + Radiation
regimen
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068237-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0003
arm key
OG000
arm label
Surgery + Transfer + Radiation
regimen
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068237-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0004
arm key
OG000
arm label
Surgery + Transfer + Radiation
regimen
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068237-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
outcome key
om-0005
arm key
OG000
arm label
Surgery + Transfer + Radiation
regimen
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068237-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
harm key
EG000
source section id
NCT00068237-ae
event group key
EG000
event group label
Surgery + Transfer + Radiation
serious affected
2
serious at risk
44
other affected
38
other at risk
44
frequency threshold
0
collection period
Source null
event definition
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
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

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00068237
qol key
qol-0003
source section id
NCT00068237-om-0003
source outcome index
3
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health related quality' in the study's own wording
scale title
Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
measure definition
The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.
time frame
Baseline and one year
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible patients with both baseline and 1-year questionnaire completed
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice