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To determine 2-year local (primary tumor site) control and toxicity rates in patients receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of the oropharynx.
To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of the oropharynx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Phase 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORS | Procedure |
| ||
| Adjuvant Radiation Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Control | 2 years |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Lin, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31785337 | Derived | Swisher-McClure S, Lukens JN, Aggarwal C, Ahn P, Basu D, Bauml JM, Brody R, Chalian A, Cohen RB, Fotouhi-Ghiam A, Geiger G, Gershowitz J, Livolsi V, Mitra N, Montone K, Newman J, Ojerholm E, O'Malley B Jr, Rajasekaran K, Tan E, Weinstein G, Lin A. A Phase 2 Trial of Alternative Volumes of Oropharyngeal Irradiation for De-intensification (AVOID): Omission of the Resected Primary Tumor Bed After Transoral Robotic Surgery for Human Papilloma Virus-Related Squamous Cell Carcinoma of the Oropharynx. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):725-732. doi: 10.1016/j.ijrobp.2019.11.021. Epub 2019 Nov 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Phase 2 | Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 24, 2017 |
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|
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Phase 2 | TORS Adjuvant Radiation Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Participants With Local Control | Posted | Number | 95% Confidence Interval | percentage of patients | 2 years |
|
|
|
2 years
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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 | Single Arm Phase 2 | TORS Adjuvant Radiation Therapy | 0 | 60 | 18 | 60 | 43 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis radiation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Esophageal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Other Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Dermatitits radiation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Other Ear and labyrinth disorders | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Edema face | General disorders | Non-systematic Assessment |
| ||
| Esophageal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Other Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| Other General disorders and administration site conditions | General disorders | Non-systematic Assessment |
| ||
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Lip pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lymphedema | Vascular disorders | Non-systematic Assessment |
| ||
| Mucosal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Other Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Neck edema | General disorders | Non-systematic Assessment |
| ||
| Other Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Salivary duct inflammation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Voice alteration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Weight loss | Investigations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Lin, MD | University of Pennsylvania | (215) 662-3198 | alexander.lin@uphs.upenn.edu |
| Oct 9, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|