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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Clump, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside Radiation Oncology | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Observation | No Stereotactic Body Radiotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients participating in the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients with/without SBRT treatment. | Posted | Median | 95% Confidence Interval | months | Up to 1 year |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara M. Stadterman, MPH, MSCR, CCRP | UPMC Hillman Cancer Center | 412-647-5554 | stadtermanbm@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2020 | Oct 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 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. | 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. | 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. | 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. | 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. | 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. | Up to 2 years |
| BG001 | Observation Cohort | No Stereotactic Body Radiotherapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Karnofsky Performance Status (KPS) | The Karnofsky Performance Status (KPS) scores range 0 - 100. Higher KPS scores means the patient is better able to carry out daily activities, used to determine a patient's prognosis, and used to measure changes in a patient's overall ability to function. | Median | Inter-Quartile Range | score on a scale |
|
| OG001 | Observation Cohort | No Stereotactic Body Radiotherapy treatment |
|
|
| Secondary | 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. | Patients with/without SBRT treatment. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| Secondary | 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. | Patients with/without SBRT treatment. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| Secondary | 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. | Patients with/without SBRT treatment. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
|
|
| Secondary | 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. | Patients with/without SBRT treatment. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
|
|
| Secondary | 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. | Patients with/without SBRT treatment. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
|
|
| Secondary | Overall Survival (OS) | The overall survival time is the measurement of time between the date of randomization and death from any cause. | Patients with/without SBRT treatment. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
|
|
|
| Secondary | 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. | Patients with/without SBRT treatment. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 2 years |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Observation Cohort | No Stereotactic Body Radiotherapy treatment | 2 | 4 | 0 | 4 | 2 | 4 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphonia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Odynophagia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Radiation Dermatitis | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Xerostomia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fibrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Otalgia | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection (Thrush) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Ulceration | General disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Grade 1 Dysphonia |
|
| Grade 1 Edema |
|
| Grade 1 Fatigue |
|
| Grade 1 Lymphedema |
|
| Grade 1 Odynophagia |
|
| Grade 1 Pain |
|
| Grade 1 Radiation Dermatitis |
|
| Grade 1 Xerostomia |
|
| Grade 2 Xerostomia |
|
| Grade 2 Pain |
|
| Grade 1 Dysgeusia |
|
| Grade 2 Fibrosis |
|
| Grade 1 Jaw Pain |
|
| Grade 1 Otalgia |
|
| Grade 1 telangiectasia |
|
| Grade 1 Trismus |
|
| Grade 1 Dysgeusia |
|
| Dysphagia |
|
| Grade 1 Fatigue |
|
| Grade 1 Fibrosis |
|
| Grade 2 Fibrosis |
|
| Grade 2 Infection (Thrush) |
|
| Grade 1 Lymphedema |
|
| Grade 2 Lymphedema |
|
| Grade 2 Pain |
|
| Grade 1 Trismus |
|
| Grade 2 Ulceration |
|
| Grade 1 Xerostomia |
|
| Grade 2 Xerostomia |
|
| Period 3: Pain |
|
| Period 1: Appearance |
|
| Period 2: Appearance |
|
| Period 3: Appearance |
|
| Period 1: Activity |
|
| Period 2: Activity |
|
| Period 3: Activity |
|
| Period 1: Recreation |
|
| Period 2: Recreation |
|
| Period 3: Recreation |
|
| Period 1: Swallowing |
|
| Period 2: Swallowing |
|
| Period 3: Swallowing |
|
| Period 1: Chewing |
|
| Period 2: Chewing |
|
| Period 3: Chewing |
|
| Period 1: Speech |
|
| Period 2: Speech |
|
| Period 3: Speech |
|
| Period 1: Shoulder |
|
| Period 2: Shoulder |
|
| Period 3: Shoulder |
|
| Period 1: Taste |
|
| Period 2: Taste |
|
| Period 3: Taste |
|
| Period 1: Saliva |
|
| Period 2: Saliva |
|
| Period 3: Saliva |
|
| Period 1: Mood |
|
| Period 2: Mood |
|
| Period 3: Mood |
|
| Period 1: Anxiety |
|
| Period 2: Anxiety |
|
| Period 3: Anxiety |
|