An interventional study of Stereotactic Body Radiotherapy in Head and Neck Cancer, sponsored by David A. Clump, MD, PhD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-14.
Sponsored by David A. Clump, MD, PhD · Not applicable, Interventional, and Treatment
Comparison of patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.
This study aims to determine prognostic factors that may predict the likelihood of local failure, regional failure, to guide future management, to compare the impact of adjuvant SBRT versus a wait-and-see approach on patient reported quality of life (PR-QoL), and to compare surgical versus SBRT-induced immunological serum markers in relation to local control. Recruitment includes patients with recurrent or second-primary head-and-neck squamous cell carcinomas within a previously-irradiated field with high-risk features compromised/positive surgical margins or extra-nodal extension) following macroscopic complete (R0/R1) salvage surgery.
Participants receive 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. Evaluations to compare the efficacy of adjuvant SBRT versus wait-and-see, include Local Control, Regional and distant control, Progression-free survival, Overall survival and Patient-Reported Quality-of-Life (PR-QoL).
Evaluations conducted to assess the safety of adjuvant SBRT following salvage surgery include recording of all toxicity data per National Cancer Institute Common Toxicity Criteria Events Scale version 4.0 and prospectively administering the previously-validated University of Washington Quality-of-Life-Revised (UW-QoL-R) questionnaire measuring patient-reported quality-of-life (PR-QoL).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
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Browse Head and Neck Neoplasms studies →David A. Clump, MD, PhD is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects will receive 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.
Radiation: Stereotactic Body Radiotherapy
Radiation
Also known as: SBRT
1-year Local Control
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.
Time frame: Up to 1 year
Number of Participants With Acute Toxicities of Adjuvant SBRT
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.
Time frame: Up to 2 years
Number of Participants With Late Toxicities of Adjuvant SBRT
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.
Time frame: Up to 2 years
Progression-free Survival (PFS) Locoregional
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.
Time frame: Up to 2 years
Progression-free Survival (DPFS) Distant
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.
Time frame: Up to 2 years
Overall Progression Free Survival (PFS)
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.
Time frame: Up to 2 years
Overall Survival (OS)
The overall survival time is the measurement of time between the date of randomization and death from any cause.
Time frame: Up to 5 years
Quality of Life (UW-QoL-R)
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.
Time frame: Up to 2 years
| Milestone | Stereotactic Body Radiotherapy | Observation |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 4 |
| Not completed | 0 | 0 |
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.
| months | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| 1-year Local Control | NA (NA to NA) | NA (2 to NA) |
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.
| Participants | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| Grade 3 - Oral Mucositis | 1 | 0 |
| Grade 1 Dysphagia | 1 | 1 |
| Grade 1 Dysphonia | 1 | 0 |
| Grade 1 Edema | 1 | 0 |
| Grade 1 Fatigue | 1 | 1 |
| Grade 1 Lymphedema | 1 | 1 |
| Grade 1 Odynophagia | 1 | 0 |
| Grade 1 Pain | 1 | 0 |
| Grade 1 Radiation Dermatitis | 1 | 0 |
| Grade 1 Xerostomia | 1 | 1 |
| Grade 2 Xerostomia | 1 | 0 |
| Grade 2 Pain | 1 | 0 |
| Grade 1 Dysgeusia | 0 | 1 |
| Grade 2 Fibrosis | 0 | 1 |
| Grade 1 Jaw Pain | 0 | 1 |
| Grade 1 Otalgia | 0 | 1 |
| Grade 1 telangiectasia | 0 | 1 |
| Grade 1 Trismus | 0 | 1 |
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.
| Participants | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| Grade 3 Pneumonia | 1 | 0 |
| Grade 1 Aspiration | 2 | 0 |
| Grade 1 Dysgeusia | 2 | 0 |
| Dysphagia | 1 | 0 |
| Grade 1 Fatigue | 1 | 0 |
| Grade 1 Fibrosis | 1 | 0 |
| Grade 2 Fibrosis | 1 | 0 |
| Grade 2 Infection (Thrush) | 1 | 0 |
| Grade 1 Lymphedema | 1 | 0 |
| Grade 2 Lymphedema | 1 | 0 |
| Grade 2 Pain | 1 | 0 |
| Grade 1 Trismus | 1 | 0 |
| Grade 2 Ulceration | 1 | 0 |
| Grade 1 Xerostomia | 1 | 0 |
| Grade 2 Xerostomia | 1 | 0 |
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.
| months | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| Progression-free Survival (PFS) Locoregional | NA (NA to NA) | NA (2 to NA) |
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.
| months | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| Progression-free Survival (DPFS) Distant | NA (NA to NA) | NA (11 to NA) |
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.
| months | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| Overall Progression Free Survival (PFS) | NA (NA to NA) | NA (2 to NA) |
The overall survival time is the measurement of time between the date of randomization and death from any cause.
| months | Stereotactic Body Radiotherapy | Observation |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
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.
| score on a scale | Stereotactic Body Radiotherapy | Observation |
|---|---|---|
| Period 1: Pain | 100.00 (100.00 to 100.00) | 75.00 (75.00 to 75.00) |
| Period 2: Pain | 100.00 (100.00 to 100.00) | 75.00 (37.50 to 100.00) |
| Period 3: Pain | 75.00 (50.00 to 75.00) | NA (NA to NA) |
| Period 1: Appearance | 75.00 (75.00 to 75.00) | 75.00 (75.00 to 75.00) |
| Period 2: Appearance | 50.00 (50.00 to 50.00) | 87.50 (50.00 to 100.00) |
| Period 3: Appearance | 75.00 (62.50 to 100.00) | NA (NA to NA) |
| Period 1: Activity | 50.00 (50.00 to 50.00) | 75.00 (75.00 to 75.00) |
| Period 2: Activity | 50.00 (50.00 to 50.00) | 75.00 (62.50 to 87.50) |
| Period 3: Activity | 62.50 (62.50 to 75.00) | NA (NA to NA) |
| Period 1: Recreation | 62.50 (50.00 to 75.00) | 75.00 (75.00 to 75.00) |
| Period 2: Recreation | 25.00 (25.00 to 25.00) | 75.00 (62.50 to 87.50) |
| Period 3: Recreation | 62.50 (62.50 to 75.00) | NA (NA to NA) |
| Period 1: Swallowing | 67.00 (67.00 to 67.00) | 67.00 (67.00 to 67.00) |
| Period 2: Swallowing | 67.00 (67.00 to 67.00) | 67.00 (33.50 to 83.50) |
| Period 3: Swallowing | 67.00 (67.00 to 67.00) | NA (NA to NA) |
| Period 1: Chewing | 50.00 (0.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Period 2: Chewing | 50.00 (50.00 to 50.00) | 75.00 (50.00 to 100.00) |
| Period 3: Chewing | 50.00 (50.00 to 100.00) | NA (NA to NA) |
| Period 1: Speech | 75.25 (67.00 to 83.50) | 67.00 (67.00 to 67.00) |
| Period 2: Speech | 33.00 (33.00 to 33.00) | 100.00 (100.00 to 100.00) |
| Period 3: Speech | 67.00 (66.50 to 100.00) | NA (NA to NA) |
| Period 1: Shoulder | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Period 2: Shoulder | 100.00 (100.00 to 100.00) | 100.00 (83.50 to 100.00) |
| Period 3: Shoulder | 67.00 (66.50 to 100.00) | NA (NA to NA) |
| Period 1: Taste | 50.00 (33.00 to 67.00) | 67.00 (67.00 to 67.00) |
| Period 2: Taste | 33.00 (33.00 to 33.00) | 67.00 (50.00 to 83.50) |
| Period 3: Taste | 67.00 (50.00 to 67.00) | NA (NA to NA) |
| Period 1: Saliva | 50.00 (33.00 to 67.00) | 67.00 (67.00 to 67.00) |
| Period 2: Saliva | 0.00 (0.00 to 0.00) | 83.50 (50.00 to 100.00) |
| Period 3: Saliva | 67.00 (33.00 to 76.00) | NA (NA to NA) |
| Period 1: Mood | 75.00 (75.00 to 75.00) | 75.00 (75.00 to 75.00) |
| Period 2: Mood | 50.00 (50.00 to 50.00) | 75.00 (50.00 to 75.00) |
| Period 3: Mood | 75.00 (75.00 to 75.00) | NA (NA to NA) |
| Period 1: Anxiety | 83.50 (67.00 to 100.00) | 67.00 (67.00 to 67.00) |
| Period 2: Anxiety | 67.00 (67.00 to 67.00) | 67.00 (50.00 to 83.50) |
| Period 3: Anxiety | 100.00 (67.00 to 100.00) | NA (NA to NA) |
Collected over Up to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stereotactic Body Radiotherapy | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Observation Cohort | 2/4 (50%) | 0/4 (0%) | 2/4 (50%) |
| Event | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| Oral MucositisGastrointestinal disorders | 1/3 | 0/4 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/3 | 0/4 |
| Event | Stereotactic Body Radiotherapy | Observation Cohort |
|---|---|---|
| LymphedemaVascular disorders | 3/3 | 1/4 |
| PainGeneral disorders | 3/3 | 1/4 |
| XerostomiaGastrointestinal disorders | 3/3 | 1/4 |
| DysphagiaGastrointestinal disorders | 2/3 | 1/4 |
| FatigueGeneral disorders | 2/3 | 1/4 |
| DysgeusiaNervous system disorders | 2/3 | 1/4 |
| FibrosisMusculoskeletal and connective tissue disorders | 2/3 | 1/4 |
| AspirationRespiratory, thoracic and mediastinal disorders | 2/3 | 0/4 |
| DysphoniaInvestigations | 1/3 | 0/4 |
| EdemaGeneral disorders | 1/3 | 0/4 |
All patients participating in the trial.
| Age, Continuous(years) | Stereotactic Body Radiotherapy | Observation Cohort | Total |
|---|---|---|---|
| Median | 63 (58.00 to 67.00) | 64 (58.00 to 71.50) | 63 (58 to 67) |
| Sex: Female, Male(Participants) | Stereotactic Body Radiotherapy | Observation Cohort | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 1 | 4 | 5 |
| Race (NIH/OMB)(Participants) | Stereotactic Body Radiotherapy | Observation Cohort | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 4 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Karnofsky Performance Status (KPS)(score on a scale) | Stereotactic Body Radiotherapy | Observation Cohort | Total |
|---|---|---|---|
| Median | 80.0 (60.00 to 80.00) | 80.0 (80.00 to 85.00) | 80.0 (80.0 to 80.0) |
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David A. Clump, MD, PhD