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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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Photon beam radiation is the standard type of radiation used to treat nasopharyngeal carcinoma. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor and leaves the body through healthy tissue. Proton beam radiation has been shown to have the same effect on tumors as photon beam radiation but it enters the body, passes through healthy tissue, and encounters the tumor but then stops. This means less healthy tissue is affected by proton beam treatment than by photon beam treatment. The purpose of this study is to determine the effectiveness of proton beam radiation in treating nasopharyngeal cancer and reducing the acute and long-term side effects from the treatment. This study will also test to see if the sparing of the healthy tissue can improve quality of life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton/Photon Radiotherapy, Cisplatin, Fluorouracil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton/Photon Radiotherapy | Radiation | Given once a day, five days a week, for seven weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Toxicity | Acute toxicities are side affects that occur during treatment and 90 days after completion. | 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total |
| Participant Compliance Rate to Assigned Treatment Intervention | 2 years | |
| Sialometry to Evaluate Xerostomia (Dry Mouth) | Sialometry is a measure of saliva flow. The normal daily production of saliva varies between 0.5 and 1.5 liters. Stimulated saliva is produced in response to a mechanical, gustatory, olfactory, or pharmacological stimulus, contributing to around 40-50% of daily salivary production. In adults, normal total stimulated salivary flow ranges 1-3 mL/minute, low ranges 0.7-1.0 mL/minute, while hyposalivation is characterized by a stimulated salivary flow <0.7mL/minute. | Baseline and 2 years (24 months) |
| Penetration-aspiration Scale to Evaluate Swallowing Function | The videofluoroscopic swallow study (VFSS) is the gold standard diagnostic tool to evaluate oropharyngeal dysphagia. The penetration-aspiration scale (PAS) is an 8-point scale used to grade the severity of penetration or aspiration observed in a videofluoroscopic swallow study. Aspiration is defined as the passing of the bolus below the true vocal folds, and penetration is when the bolus enters the airway but not below the true vocal folds. 1 is normal, no penetration or aspiration. 2-5 is penetration. 6-8 is aspiration. | Baseline and 12 months |
| Serial Measurements of Maximal Inter-incisal Distance to Evaluate Trismus (Lockjaw) | Serial measures of the changes of the maximal inter-incisal distance in the vertical opening, right lateral, and left lateral jaw movements are used to evaluate trismus (lockjaw). An average measurement of the three directional areas will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Pattern of Locoregional Tumor Recurrence | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annie W Chan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
Not provided
Study period: 2006 and 2011 Location: Outpatient clinic at the Massachusetts General Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton/Photon Radiotherapy, Cisplatin, Fluorouracil | Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks. Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles. Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton/Photon Radiotherapy, Cisplatin, Fluorouracil | Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks. Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles. Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after 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 |
| 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 | Number of Participants With Acute Toxicity | Acute toxicities are side affects that occur during treatment and 90 days after completion. | Posted | Count of Participants | Participants | 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total |
|
|
Toxicity evaluation occurred during protocol therapy and 5+ years of follow-up.
Adverse events were routinely collected through regular investigator assessment and regular laboratory testing.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton/Photon Radiotherapy, Cisplatin, Fluorouracil | Proton/Photon Radiotherapy: Given once a day, five days a week, for seven weeks. Cisplatin: Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles. Fluorouracil: Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0) | Systematic Assessment | "jittery" |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie W. Chan, MD | Massachusetts General Hospital | 617-726-5184 | AWCHAN@PARTNERS.ORG |
Not provided
| 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 | Jun 21, 2011 | Jun 1, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2012 | Jun 2, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011522 | Protons |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cisplatin | Drug | Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles. |
|
| Fluorouracil | Drug | Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy. |
|
|
| Baseline and 2 years |
| ChemoSensory Questionnaire (CSQ) to Evaluate Smell and Taste Function | The Chemosensory Questionnaire (CSQ) has four questions each on smell and taste. A minimum score of 4 and a maximum of 20 for the smell scale and taste scale are possible with a higher score indicating better function. | 2 years |
| Number of Participants With Speech Problems Assessed by Head and Neck Health Status Assessment Inventory (HNHSAI) | The Head and Neck Health Status Assessment Inventory (HNHSAI) is a descriptive outcome assessment consisting of 14 yes/no questions to measure number of participants with speech problems. | 2 years |
| Health Related Quality-of-Life Outcomes Using Validated Quality-of-Life Instrument EORTC QLQ-C30 | General quality of life is measured with the European organization for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ) EORTC QLQ-C30 (cancer 30). They are self-administered questionnaires. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for the global health status / QoL represents a high QoL. | 2 years |
| Health Related Quality-of-life Outcomes Using Validated Quality-of-life Instrument EORTC-QLQ-H&N | General quality of life is measured with the European organization for research and treatment of cancer (EORTC) quality of life questionnaires (QLQ) for head and neck (H&N) (EORTC-QLQ-H&N). The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. All of the scales and single-item measures range in score from 0 to 100. For all items and symptom scales, high scores represent a high level of symptomatology/problems. | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Participants |
| No |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Participant Compliance Rate to Assigned Treatment Intervention | Posted | Number | percentage of participants | 2 years |
|
|
|
| Primary | Sialometry to Evaluate Xerostomia (Dry Mouth) | Sialometry is a measure of saliva flow. The normal daily production of saliva varies between 0.5 and 1.5 liters. Stimulated saliva is produced in response to a mechanical, gustatory, olfactory, or pharmacological stimulus, contributing to around 40-50% of daily salivary production. In adults, normal total stimulated salivary flow ranges 1-3 mL/minute, low ranges 0.7-1.0 mL/minute, while hyposalivation is characterized by a stimulated salivary flow <0.7mL/minute. | The mean values below are for all analyzed participants. | Posted | Mean | Standard Deviation | milliliters | Baseline and 2 years (24 months) |
|
|
|
| Primary | Penetration-aspiration Scale to Evaluate Swallowing Function | The videofluoroscopic swallow study (VFSS) is the gold standard diagnostic tool to evaluate oropharyngeal dysphagia. The penetration-aspiration scale (PAS) is an 8-point scale used to grade the severity of penetration or aspiration observed in a videofluoroscopic swallow study. Aspiration is defined as the passing of the bolus below the true vocal folds, and penetration is when the bolus enters the airway but not below the true vocal folds. 1 is normal, no penetration or aspiration. 2-5 is penetration. 6-8 is aspiration. | Posted | Mean | Full Range | score on a scale | Baseline and 12 months |
|
|
|
| Primary | Serial Measurements of Maximal Inter-incisal Distance to Evaluate Trismus (Lockjaw) | Serial measures of the changes of the maximal inter-incisal distance in the vertical opening, right lateral, and left lateral jaw movements are used to evaluate trismus (lockjaw). An average measurement of the three directional areas will be reported. | Posted | Mean | Standard Deviation | millimeters | Baseline and 2 years |
|
|
|
| Primary | ChemoSensory Questionnaire (CSQ) to Evaluate Smell and Taste Function | The Chemosensory Questionnaire (CSQ) has four questions each on smell and taste. A minimum score of 4 and a maximum of 20 for the smell scale and taste scale are possible with a higher score indicating better function. | Posted | Median | Standard Error | score on a scale | 2 years |
|
|
|
| Primary | Number of Participants With Speech Problems Assessed by Head and Neck Health Status Assessment Inventory (HNHSAI) | The Head and Neck Health Status Assessment Inventory (HNHSAI) is a descriptive outcome assessment consisting of 14 yes/no questions to measure number of participants with speech problems. | Posted | Number | participants | 2 years |
|
|
|
| Primary | Health Related Quality-of-Life Outcomes Using Validated Quality-of-Life Instrument EORTC QLQ-C30 | General quality of life is measured with the European organization for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ) EORTC QLQ-C30 (cancer 30). They are self-administered questionnaires. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for the global health status / QoL represents a high QoL. | Posted | Median | Standard Deviation | Global Health Status score on a scale | 2 years |
|
|
|
| Primary | Health Related Quality-of-life Outcomes Using Validated Quality-of-life Instrument EORTC-QLQ-H&N | General quality of life is measured with the European organization for research and treatment of cancer (EORTC) quality of life questionnaires (QLQ) for head and neck (H&N) (EORTC-QLQ-H&N). The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. All of the scales and single-item measures range in score from 0 to 100. For all items and symptom scales, high scores represent a high level of symptomatology/problems. | Posted | Mean | Standard Error | dry mouth score on a scale | 2 years |
|
|
|
| Secondary | Rate and Pattern of Locoregional Tumor Recurrence | Posted | Number | participants | 3 years |
|
|
|
| 6 |
| 23 |
| 1 |
| 23 |
| 23 |
| 23 |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Neutropenia |
|
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | acid reflux |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | acute renal failure |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Alkaline phosphatase increased |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | ALT increased |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | ANC increased |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Anemia (hemoglobin decreased) |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | AST increased |
|
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - other | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Candidiasis |
|
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0) | Systematic Assessment | Carboplatin extravasation |
|
| Cardiac troponin T (cTnT) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infections - skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| CNS necrosis/cystic progression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | CNS necrosis |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Salivary gland changes/saliva | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration - Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | desquamation |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ophthalmoplegia/ diplopia (double vision) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment | DVT: left leg |
|
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | hoarseness |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurology - other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Dysosmia |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphatics - other | General disorders | CTCAE (3.0) | Systematic Assessment | Edema unspecified |
|
| Edema: head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, pulmonary/upper respiratory - nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Epistaxis |
|
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Erythema unspecified |
|
| Extrapyramidal/ involuntary movement/restlessness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Soft palate defect |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - head/headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing: patients with/without baseline audiogram and enrolled in a monitoring program | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment | Hearing loss |
|
| Hemorrhage/Bleeding - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Hemorrhage unspecified |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thyroid function, low (hypothyroidism) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ileus, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | "increased transaminase/LFT" |
|
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | c diff |
|
| Mucositis/stomatitis - oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | thrush/oral mucositis |
|
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Auditory/Ear - Other | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment | ear fullness |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - extremity-limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | leukocytes decreased |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0) | Systematic Assessment | mucositis unspecified |
|
| Mucositis/stomatitis - pharynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | nasal congestion |
|
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Nasal Stenosis |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | neck stiffness |
|
| Neurology - Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | neuropathy unspecified |
|
| Apnea | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Odynophagia |
|
| Pain: oral-gums | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Middle ear (otitis media) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - other | General disorders | CTCAE (3.0) | Systematic Assessment | pain at g-tube site |
|
| pain - anus | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - back | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - other | General disorders | CTCAE (3.0) | Systematic Assessment | ear pain unspecified |
|
| pain - face | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - eye | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - middle ear | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - chest wall | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - oral cavity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain - throat/pharynx/larynx | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Pancytopenia |
|
| neurology - other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | peripheral neuropathy unspecified |
|
| platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | platelets decreased |
|
| infection - bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| pain - joint | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Pneumomediastinum |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vasovagal episode | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Trismus (difficulty, restriction or pain when opening mouth) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection - upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Sebaceous Cysts |
|
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Rhinorrhea |
|
| Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Soft palate fusion to post-oropharynx |
|
| Dermatology/Skin --Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Skin breakdown - lips |
|
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | rash unspecified |
|
| Renal/Genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | renal insufficiency |
|
| Infection - Other | Infections and infestations | CTCAE (3.0) | Systematic Assessment | ear infection unspecified |
|
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | restless leg syndrome |
|
| Rash: dermatitis associated with radiation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Thromboplebitis (left arm) |
|
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0) | Systematic Assessment | thick mucus, unspecified |
|
Not provided
Not provided
Not provided
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|