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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00026771 | Other Identifier | JHM IRB |
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This research is being done to try to reduce radiation side effects that happen with the standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy are standard treatment for people with squamous cell carcinoma of the oropharynx.
The study will look at giving a slightly smaller dose of radiation (de-intensification) to see if regularly expected late toxicities (two years after receiving treatment) can be reduced. This study will also try to see if the smaller dose of radiation is equally effective at treating the cancer and to see if it improves quality of life. Along with this radiation treatment plan some participants in this study will have surgery on their tumor and or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy will be up to the participant's doctor.
Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose de-escalating radiation therapy with chemotherapy | Experimental | This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT | Radiation | Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Free of Grade 3+ Late Toxicity | The goal is to achieve a prevalence of < 15% grade 3+ late toxicity at 2 years; reported as percentage of patients who were free of grade 3+ adverse events (AEs) as measured by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) between 6 months and 24 months. The outcome is reported as percentage of patients who were free of grade 3+ adverse events. | 2 years |
| Percentage of Patients With Locoregional Tumor Control | Locoregional tumor control > 85 + or - 7% at 2 years; measured through progression-free survival (the time from assignment in a clinical trial to disease progression or death from any cause). Locoregional tumor control is reported as percentage of patients meeting this criteria. | 2 years |
| Adverse Events and Their Cause | To determine the nature and prevalence of side effects at different time intervals and describe their relationship to pretreatment function and local dose and treated volume. | Pretreatment, 3 months, then every 3 months for the first 2 years, then every 6 months for years 3-5 |
| Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI) | Determine quality of life of surviving patients measured by patient reported outcomes: -MDADI-Self-administered assessment on patient swallowing ability. There are 19 questions specific to swallowing that study patients completed. Composite score is the average of the 19 questions. The scale is 20 (extremely low functioning) to 100 (high functioning). Composite score is reported. | Baseline, 6-8 weeks, 6 months, 1 year, 2 years, 3 years, 4-5 year visit |
| Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quon Harry, M.D. | Johns Hopkins University | Principal Investigator |
| Arlene Forastiere, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
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Patients were recruited from Johns Hopkins' Radiation/Medical Oncology clinics from 2010-2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose De-escalating Radiation Therapy With Chemotherapy | This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment. Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose De-escalating Radiation Therapy With Chemotherapy | This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment. Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance. |
| 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 | Percentage of Patients Free of Grade 3+ Late Toxicity | The goal is to achieve a prevalence of < 15% grade 3+ late toxicity at 2 years; reported as percentage of patients who were free of grade 3+ adverse events (AEs) as measured by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) between 6 months and 24 months. The outcome is reported as percentage of patients who were free of grade 3+ adverse events. | 5/60 patients did not have adverse event data captured for the period. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
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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 | Dose De-escalating Radiation Therapy With Chemotherapy | This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment. Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harry Quon, MD | Johns Hopkins Medicine | 410-502-3877 | hquon2@jhmi.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 | Mar 29, 2022 | Oct 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment. |
|
| Carboplatin | Drug | Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance. |
|
Determine quality of life of surviving patients measured by patient reported outcomes: MDASI-HN-Self-reported assessment. Measures symptom severity in previous day. Study patients answered 9 specific questions specific to head and neck cancer. Symptom severity scores, from 0 (not present) to 10 (worst possible). Composite score calculated average of individual scores. Mean module (head and neck) symptom severity is reported. |
| Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit |
| Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ) | Determine quality of life of surviving patients measured by patient reported outcomes: XQ measures severity of radiation-induced xerostomia and patient reported quality of life. 8 question total:4 on dryness while eating/chewing, 4 on dryness when not eating/chewing. 0-10 (higher scores=severe dryness/discomfort). Composite Scores range from 0 (no xerostomia) -100 (highest level of xerostomia). | Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Patients With Locoregional Tumor Control | Locoregional tumor control > 85 + or - 7% at 2 years; measured through progression-free survival (the time from assignment in a clinical trial to disease progression or death from any cause). Locoregional tumor control is reported as percentage of patients meeting this criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Primary | Adverse Events and Their Cause | To determine the nature and prevalence of side effects at different time intervals and describe their relationship to pretreatment function and local dose and treated volume. | Data was not collected to assess this outcome. | Posted | Pretreatment, 3 months, then every 3 months for the first 2 years, then every 6 months for years 3-5 |
|
|
| Primary | Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI) | Determine quality of life of surviving patients measured by patient reported outcomes: -MDADI-Self-administered assessment on patient swallowing ability. There are 19 questions specific to swallowing that study patients completed. Composite score is the average of the 19 questions. The scale is 20 (extremely low functioning) to 100 (high functioning). Composite score is reported. | Some patients did not respond to QoL assessment for the various time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-8 weeks, 6 months, 1 year, 2 years, 3 years, 4-5 year visit |
|
|
|
| Primary | Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN) | Determine quality of life of surviving patients measured by patient reported outcomes: MDASI-HN-Self-reported assessment. Measures symptom severity in previous day. Study patients answered 9 specific questions specific to head and neck cancer. Symptom severity scores, from 0 (not present) to 10 (worst possible). Composite score calculated average of individual scores. Mean module (head and neck) symptom severity is reported. | Some patients did not respond to QoL assessment for the various time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit |
|
|
|
| Primary | Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ) | Determine quality of life of surviving patients measured by patient reported outcomes: XQ measures severity of radiation-induced xerostomia and patient reported quality of life. 8 question total:4 on dryness while eating/chewing, 4 on dryness when not eating/chewing. 0-10 (higher scores=severe dryness/discomfort). Composite Scores range from 0 (no xerostomia) -100 (highest level of xerostomia). | Some patients did not respond to QoL assessment for the various time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit |
|
|
|
| 1 |
| 60 |
| 54 |
| 60 |
| 60 |
| 60 |
| akathisia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| ANC decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| colonic obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Esophageal stricture | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| fever | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| general NOS: failure to thrive | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| hearing changes | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Hypertension | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Hypomagnesia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| injury/procedure complication: bleeding at PEG site | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| injury/procedure complication: g-tube dysfunction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| injury/procedure complication: PEG dysfunction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| injury/procedure complication-NOS: admitted following left neck dissection | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| injury/procedure complication-NOS: PEG insertion | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| lower GI hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| lung metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Metastatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Mucous membrane | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| pain | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| pain due to XRT | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Pain NCI | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| pharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| psych NOS | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| restlessness | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| saliva/salivary gland | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Subcutaneous tissue | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| vascular access complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| venous thrombosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| WBC Decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Xerostomia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| Neutrophils decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| pain | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| PsychNOS: mood disorder | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| WBC Decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| injury to carotid artery | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 5 |
|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dermal caries | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| esophageal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| esophagus/RTOG | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hearing changes | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hypomagnesia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| larynx/RTOG | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| mucous membrane/RTOG | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| pain due to XRT | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| platelets/count decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| saliva/salivary gland | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| skin acute | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| skin acute | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| skin late | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| subcutaneous tissue/RTOG | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| voice changes/alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| watery eye | Eye disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| WBC decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| weight loss | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| xerostomia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| esophagus/RTOC | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| hearing changes/impairment | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| hypomagnesia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| larynx/RTOG | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| mucous membrane/RTOG | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| pain due to XRT | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| salivary gland | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| skin acute | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| skin late | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| subcutaneous tissue | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| WBC decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| weight loss | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| xerostomia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
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| 6 month visit |
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| 1 year visit |
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| 2 year visit |
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| 3 year visit |
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| 4-5 year visit |
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| 1 year visit |
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| 2 year visit |
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| 3 year visit |
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| 4-5 year visit |
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| 1 year visit |
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| 2 year visit |
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| 3 year visit |
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| 4-5 year visit |
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