Trial Outcomes & Findings for Surgery With or Without Adjuvant Stereotactic Body Radiotherapy (NCT NCT02516969)
NCT ID: NCT02516969
Last Updated: 2022-01-14
Results Overview
Local progression-free-survival (LPFS) is the number of months from the initiation of study treatment until (local) progression of disease or death from any cause. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2022-01-14
Participant Flow
Participant milestones
| Measure |
Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation
No Stereotactic Body Radiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgery With or Without Adjuvant Stereotactic Body Radiotherapy
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
|
80.0 score on a scale
n=5 Participants
|
80.0 score on a scale
n=7 Participants
|
80.0 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Patients with/without SBRT treatment.
Local progression-free-survival (LPFS) is the number of months from the initiation of study treatment until (local) progression of disease or death from any cause. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
1-year Local Control
|
NA months
Median survival is not reached. Insufficient number of participants with event of (local) progression.
|
NA months
Interval 2.0 to
Upper bound of 95% CI not available. Insufficient number of participants with event of (local) progression.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with/without SBRT treatment.
Toxicities are assess according to the National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4. Acute toxicities are those seen within 3 months of completion of Stereotactic Body Radiotherapy. Toxicity in patients is documented immediately prior to randomization and 8-12 weeks post-treatment. Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 3 - Oral Mucositis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Dysphagia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Dysphonia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Edema
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Fatigue
|
1 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Lymphedema
|
1 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Odynophagia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Radiation Dermatitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Xerostomia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 2 Xerostomia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 2 Pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Dysgeusia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 2 Fibrosis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Jaw Pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Otalgia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 telangiectasia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Acute Toxicities of Adjuvant SBRT
Grade 1 Trismus
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with/without SBRT treatment.
Toxicities will be assessed according to the National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4. Late toxicities will be those seen after 3 months of completion of Stereotactic Body Radiotherapy. Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Xerostomia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 3 Pneumonia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Aspiration
|
2 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Dysgeusia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Dysphagia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Fatigue
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Fibrosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 2 Fibrosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 2 Infection (Thrush)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Lymphedema
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 2 Lymphedema
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 2 Pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 1 Trismus
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 2 Ulceration
|
1 Participants
|
0 Participants
|
|
Number of Participants With Late Toxicities of Adjuvant SBRT
Grade 2 Xerostomia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with/without SBRT treatment.
LRPFS is defined as the time from the date of randomization to the date of local or regional recurrence, whichever occurs first, or the date of death from any cause. Subjects who are alive and have not progressed will be censored at their last follow-up date. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Progression-free Survival (PFS) Locoregional
|
NA months
Median LRPFS not reached. The 95% CI not available. Insufficient number of participants with event of (locoregional) progression.
|
NA months
Interval 2.0 to
Median LRPFS not reached. Upper bound of 95% CI not available. Insufficient number of participants with event of (locoregional) progression.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with/without SBRT treatment.
Distant progression-free-survival (DPFS) is the time from the date of randomization to the date of distant progression or the date of death from any cause. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Progression-free Survival (DPFS) Distant
|
NA months
Median DPFS not reached. The 95% CI not available. Insufficient number of participants with event of (distant) progression.
|
NA months
Interval 11.0 to
Median DPFS not reached. Upper bound of 95% CI not available. Insufficient number of participants with event of (distant) progression.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with/without SBRT treatment.
Overall progression free survival is the total of the three survival time measurements; PFS = local + regional + distant. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Overall Progression Free Survival (PFS)
|
NA months
Median survival not reached. The 95% CI not available. Insufficient number of participants with event of progression.
|
NA months
Interval 2.0 to
Median survival not reached. Upper bound of 95% CI not available. Insufficient number of participants with event of progression.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients with/without SBRT treatment.
The overall survival time is the measurement of time between the date of randomization and death from any cause.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Median OS not reached. 95% CI was not available. Insufficient number of participants with event of death.
|
NA months
Median OS not reached. 95% CI was not available. Insufficient number of participants with event of death.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with/without SBRT treatment.
The University of Washington Quality of Life questionnaire (revised) is a self-administered 16 item inquiry given to patients with head and neck cancer. The first 12 items ask the patient to score domains (such as pain, appearance, swallowing) from 0 (worse) to 100 (best). The arithmetic mean is then computed, yielding one number between 0 and 100. The higher the number, the "better" the patient is considered to be faring. The item simply asks the patient to choose the top 3 issues which have been bothering the patient over the past 7 days. The issues include physical symptoms, emotions and appearance. The final 3 questions provide a global assessment by asking the patient to consider their overall well-being over the past 7 days and provide possible answers ranging from excellent to very poor. For trial analysis: Period=1: before surgery, Period=2: after surgery, but before SBRT for patients in the SBRT arm, Period=3: after SBRT.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=3 Participants
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 Participants
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Quality of Life (UW-QoL-R)
Period 1: Pain
|
100.00 score on a scale
Interval 100.0 to 100.0
|
75.00 score on a scale
Interval 75.0 to 75.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Pain
|
100.00 score on a scale
Interval 100.0 to 100.0
|
75.00 score on a scale
Interval 37.5 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Pain
|
75.00 score on a scale
Interval 50.0 to 75.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Appearance
|
75.00 score on a scale
Interval 75.0 to 75.0
|
75.00 score on a scale
Interval 75.0 to 75.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Appearance
|
50.00 score on a scale
Interval 50.0 to 50.0
|
87.50 score on a scale
Interval 50.0 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Appearance
|
75.00 score on a scale
Interval 62.5 to 100.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Activity
|
50.00 score on a scale
Interval 50.0 to 50.0
|
75.00 score on a scale
Interval 75.0 to 75.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Activity
|
50.00 score on a scale
Interval 50.0 to 50.0
|
75.00 score on a scale
Interval 62.5 to 87.5
|
|
Quality of Life (UW-QoL-R)
Period 3: Activity
|
62.50 score on a scale
Interval 62.5 to 75.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Recreation
|
62.50 score on a scale
Interval 50.0 to 75.0
|
75.00 score on a scale
Interval 75.0 to 75.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Recreation
|
25.00 score on a scale
Interval 25.0 to 25.0
|
75.00 score on a scale
Interval 62.5 to 87.5
|
|
Quality of Life (UW-QoL-R)
Period 3: Recreation
|
62.50 score on a scale
Interval 62.5 to 75.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Swallowing
|
67.00 score on a scale
Interval 67.0 to 67.0
|
67.00 score on a scale
Interval 67.0 to 67.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Swallowing
|
67.00 score on a scale
Interval 67.0 to 67.0
|
67.00 score on a scale
Interval 33.5 to 83.5
|
|
Quality of Life (UW-QoL-R)
Period 3: Swallowing
|
67.00 score on a scale
Interval 67.0 to 67.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Chewing
|
50.00 score on a scale
Interval 0.0 to 100.0
|
100.00 score on a scale
Interval 100.0 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Chewing
|
50.00 score on a scale
Interval 50.0 to 50.0
|
75.00 score on a scale
Interval 50.0 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Chewing
|
50.00 score on a scale
Interval 50.0 to 100.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Speech
|
75.25 score on a scale
Interval 67.0 to 83.5
|
67.00 score on a scale
Interval 67.0 to 67.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Speech
|
33.00 score on a scale
Interval 33.0 to 33.0
|
100.00 score on a scale
Interval 100.0 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Speech
|
67.00 score on a scale
Interval 66.5 to 100.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Shoulder
|
100.00 score on a scale
Interval 100.0 to 100.0
|
100.00 score on a scale
Interval 100.0 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Shoulder
|
100.00 score on a scale
Interval 100.0 to 100.0
|
100.00 score on a scale
Interval 83.5 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Shoulder
|
67.00 score on a scale
Interval 66.5 to 100.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Taste
|
50.00 score on a scale
Interval 33.0 to 67.0
|
67.00 score on a scale
Interval 67.0 to 67.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Taste
|
33.00 score on a scale
Interval 33.0 to 33.0
|
67.00 score on a scale
Interval 50.0 to 83.5
|
|
Quality of Life (UW-QoL-R)
Period 3: Taste
|
67.00 score on a scale
Interval 50.0 to 67.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Saliva
|
50.00 score on a scale
Interval 33.0 to 67.0
|
67.00 score on a scale
Interval 67.0 to 67.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Saliva
|
0.00 score on a scale
Interval 0.0 to 0.0
|
83.50 score on a scale
Interval 50.0 to 100.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Saliva
|
67.00 score on a scale
Interval 33.0 to 76.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Mood
|
75.00 score on a scale
Interval 75.0 to 75.0
|
75.00 score on a scale
Interval 75.0 to 75.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Mood
|
50.00 score on a scale
Interval 50.0 to 50.0
|
75.00 score on a scale
Interval 50.0 to 75.0
|
|
Quality of Life (UW-QoL-R)
Period 3: Mood
|
75.00 score on a scale
Interval 75.0 to 75.0
|
NA score on a scale
Survey not completed by patient(s).
|
|
Quality of Life (UW-QoL-R)
Period 1: Anxiety
|
83.50 score on a scale
Interval 67.0 to 100.0
|
67.00 score on a scale
Interval 67.0 to 67.0
|
|
Quality of Life (UW-QoL-R)
Period 2: Anxiety
|
67.00 score on a scale
Interval 67.0 to 67.0
|
67.00 score on a scale
Interval 50.0 to 83.5
|
|
Quality of Life (UW-QoL-R)
Period 3: Anxiety
|
100.00 score on a scale
Interval 67.0 to 100.0
|
NA score on a scale
Survey not completed by patient(s).
|
Adverse Events
Stereotactic Body Radiotherapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Observation Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Stereotactic Body Radiotherapy
n=3 participants at risk
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 participants at risk
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Gastrointestinal disorders
Oral Mucositis
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
Other adverse events
| Measure |
Stereotactic Body Radiotherapy
n=3 participants at risk
Stereotactic Body Radiotherapy at the following levels: Treatment Volumes \<25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
|
Observation Cohort
n=4 participants at risk
No Stereotactic Body Radiotherapy treatment
|
|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
2/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Investigations
Dysphonia
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
General disorders
Edema
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Vascular disorders
Lymphedema
|
100.0%
3/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Investigations
Odynophagia
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
General disorders
Pain
|
100.0%
3/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Gastrointestinal disorders
Xerostomia
|
100.0%
3/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis
|
66.7%
2/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Ear and labyrinth disorders
Otalgia
|
0.00%
0/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Skin and subcutaneous tissue disorders
telangiectasia
|
0.00%
0/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
25.0%
1/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
66.7%
2/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
Infections and infestations
Infection (Thrush)
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
|
General disorders
Ulceration
|
33.3%
1/3 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
0.00%
0/4 • Up to 24 months
Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events per National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4.
|
Additional Information
Barbara M. Stadterman, MPH, MSCR, CCRP
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place