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This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible patients will receive a "lead-in" period of Nelfinavir (1250 mg po bid) for 7-14 days prior to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).
This is a single-arm Phase II study of organ-preservation chemoradiotherapy given in combination with the protease inhibitor, Nelfinavir, in patients with stage II, IVa, or IVb (per AJCC version 7) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. Patients start treatment with Nelfinvir at a dose of 1250 mg twice daily for 7-14 days, before continuing Nelfinvir at this dose concurrent with chemotherapy and radiation therapy (for a total dose of 70 Gy over a period of 7 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Phase 2 | Experimental | Single Arm, Phase II study of Nelfinavir Lead-In (Period 1) Followed by Concurrent Chemoradiation with Nelfinavir (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfinavir (Viracept®) 1250 mg | Drug | Period 1: Nelfinavir Lead-In (1250 mg bid, 7-14 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional Control | locoregional control determined via diagnostic imaging and clinical examination. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Hypoxia From Nelfinavir | Decrease in Hypoxia from Nelfinavir was determined by change in uptake and volume as assessed via 18f-FMISO or 18f-EF5 PET/CT pre-Nelfinavir versus post Nelfnavir lead-in | 7-14 days |
| Change in Glucose Metabolism From Nelfinavir |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm, 2 Period, Phase 2 Trial | Period 1: Nelfinavir Lead-In (1250 mg bid, 7-14 days) Period 2: Definitive Chemoradiotherapy with Nelfinavir (70 Gy radiotherapy over 7 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nelfinavir Lead-In |
| |||||||||||||
| Chemoradiotherapy With Nelfinavir |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Phase 2 | Nelfinavir (Viracept®) 1250 mg FMISO |
| 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 |
| 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 | Locoregional Control | locoregional control determined via diagnostic imaging and clinical examination. | Posted | Number | 64.7% Confidence Interval | participants | 5 years |
|
|
Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
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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 | Nelfinavir (Viracept®) 1250 mg FMISO | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Lin, MD | University of Pennsylvania | 215-662-3198 | alexander.lin2@pennmedicine.upenn.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 3, 2020 | Oct 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019888 | Nelfinavir |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Chemoradiation | Other | Period 2: Concurrent Chemoradiation (70 Gy over 7 weeks) with Nelfinavir (1250 mg bid) |
|
Change in Glucose Metabolism from Nelfinavir was determined by change in glucose uptake as assessed via FDG-PET/CT pre-Nelfinavir versus post Nelfnavir lead-in |
| From the initiation of any study procedures to 30 days following the completion of 7 chemoradiation |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Locoregional head and neck cancer | Number | participants |
|
|
| Secondary | Decrease in Hypoxia From Nelfinavir | Decrease in Hypoxia from Nelfinavir was determined by change in uptake and volume as assessed via 18f-FMISO or 18f-EF5 PET/CT pre-Nelfinavir versus post Nelfnavir lead-in | Posted | Number | 67% Confidence Interval | participants | 7-14 days |
|
|
|
| Secondary | Change in Glucose Metabolism From Nelfinavir | Change in Glucose Metabolism from Nelfinavir was determined by change in glucose uptake as assessed via FDG-PET/CT pre-Nelfinavir versus post Nelfnavir lead-in | Posted | Count of Participants | Participants | From the initiation of any study procedures to 30 days following the completion of 7 chemoradiation |
|
|
|
| 17 |
| 17 |
| 17 |
| 17 |
| 17 |
|
| Allergic reaction | Immune system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by an adverse local or general response from exposure to an allergen. |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood. |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a loss of appetite. |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen. |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inhalation of solids or liquids into the lungs. |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation involving the gallbladder. It may be associated with the presence of gallstones. |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by difficulty in swallowing. |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation of the esophageal wall. |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve. |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar. |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a pathological increase in blood pressure |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood. |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen. |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation of the oral mucosal. |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen. |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen. |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node. |
|
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen. |
|
|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen. |
|
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase in a blood specimen. |
|
| Allergic reaction | Immune system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by an adverse local or general response from exposure to an allergen. |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood. |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a loss of appetite. |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus. |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen. |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inhalation of solids or liquids into the lungs. |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by marked discomfort sensation in the back region. |
|
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid. |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by irregular and infrequent or difficult evacuation of the bowels. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound. |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen. |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis. |
|
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by melancholic feelings of grief or unhappiness. |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment | A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by frequent and watery bowel movements. |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking. |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by reduced salivary flow in the oral cavity. |
|
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell. |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by difficulty in swallowing. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by an uncomfortable sensation of difficulty breathing. |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in the ear. |
|
| Edema face | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by swelling due to excessive fluid accumulation in facial tissues. |
|
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by swelling due to excessive fluid accumulation in the upper or lower extremities. |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by target lesions (a pink-red ring around a pale center). |
|
| Esophageal pain | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in the esophageal region. |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities. |
|
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by elevation of the body's temperature above the upper limit of normal. |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus. |
|
| Gastroparesis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by an incomplete paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine. |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve. |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by the presence of dilated veins in the rectum and surrounding area. |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by repeated gulp sounds that result from an involuntary opening and closing of the glottis. This is attributed to a spasm of the diaphragm. |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by harsh and raspy voice arising from or spreading to the larynx. |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar. |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs. |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood. |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of calcium in the blood. |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood. |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood. |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood. |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment. |
|
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by swelling due to an excessive accumulation of fluid in the larynx. |
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| Localized edema | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by swelling due to excessive fluid accumulation at a specific anatomic site. |
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| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen. |
|
| Lymphocyte count increased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an abnormal increase in the number of lymphocytes in the blood, effusions or bone marrow. |
|
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation (physiologic response to irritation), swelling and redness to the middle ear. |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation of the oral mucosal. |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a queasy sensation and/or the urge to vomit. |
|
| Neck edema | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by swelling due to an accumulation of excessive fluid in the neck. |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by marked discomfort sensation in the neck area. |
|
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in the mouth, tongue or lips. |
|
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by the sensation of marked discomfort, distress or agony. |
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| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen. |
|
| Prostatic pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in the prostate gland. |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by the presence of macules (flat) and papules (elevated) |
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| Salivary duct inflammation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by inflammation of the salivary duct. |
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| Somnolence | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by characterized by excessive sleepiness and drowsiness. |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by of marked discomfort in the throat |
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| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in the stomach. |
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| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by occlusion of a vessel by a thrombus that has migrated from a distal site via the blood stream. |
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| Tinnitus | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by noise in the ears, such as ringing, buzzing, roaring or clicking. |
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| Tremor | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by the uncontrolled shaking movement of the whole body or individual parts. |
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| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by a change in the sound and/or speed of the voice. |
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| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth. |
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| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment | A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve. |
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| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment | A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen. |
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| Infections and infestations | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Infections and infestations |
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| Investigations | Investigations | CTCAE (5.0) | Systematic Assessment | Investigations |
|
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |