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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000287213 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).
PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo surgical transfer of the submandibular salivary gland to the submental space.
Within 4-6 weeks after surgery, patients undergo radiotherapy once daily, 5 days a week for 5 ½ to 7 weeks in the absence of disease progression or unacceptable toxicity.
Salivary scans are performed before surgery, at 2-3 weeks after surgery, and then at 6 months from the start of radiotherapy.
Quality of life is assessed at baseline and at 3, 6, and 12 months from the start of radiotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years and then annually.
PROJECTED ACCRUAL: A total of 11-48 patients will be accrued for this study within 1.6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery + Transfer + Radiation | Experimental | Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salivary gland transfer | Procedure | Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" | Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%. | At the time of the submandibular salivary gland transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Acute Xerostomia | The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements). | From start of treatment to 90 days |
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DISEASE CHARACTERISTICS:
One of the following diagnoses:
No N3 disease
No carcinoma of the oral cavity or nasopharynx
No bilateral neck node involvement
No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI
No pre-epiglottic space involvement
No involvement of level 1 nodes on either side of the neck
No salivary gland malignancy
No recurrent disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Naresh Jha, MBBS | Cross Cancer Institute at University of Alberta | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States | ||
| University of Miami Sylvester Comprehensive Cancer Center - Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22541957 | Result | Jha N, Harris J, Seikaly H, Jacobs JR, McEwan AJ, Robbins KT, Grecula J, Sharma AK, Ang KK. A phase II study of submandibular gland transfer prior to radiation for prevention of radiation-induced xerostomia in head-and-neck cancer (RTOG 0244). Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):437-42. doi: 10.1016/j.ijrobp.2012.02.034. Epub 2012 Apr 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery + Transfer + Radiation | Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Post-operative radiation therapy | Radiation | Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery. |
|
| Percentage of Patients With Normal Functioning Transferred Submandibular Gland | Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained. | Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks) |
| Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire | The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement. | Baseline and one year |
| Percentage of Patients Experiencing Facial Edema Following Surgery | Facial edema was noted as present or absent following surgery. | From surgery to 30 days after surgery |
| Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy | Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy. | From start of radiation therapy to 90 days |
| Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy | Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Late" refers to toxicities occurring at least 91 days from the start of radiation therapy. | From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years. |
| Disease-free Survival Rate at 2 Years | Failure was defined as local, regional, or distant recurrence/progression, second primary tumor, or death due to any cause. Disease-free survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Disease-free survival rate is estimated using the kaplan-meier method. | From registration to two years |
| Overall Survival Rate at 2 Years | Failure was defined as death due to any cause. Survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Survival rate is estimated using the kaplan-meier method. | From registration to two years |
| Miami |
| Florida |
| 33136 |
| United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients who started study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Surgery + Transfer + Radiation | Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" | Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%. | Eligible patients who started study treatment. | Posted | Number | participants | At the time of the submandibular salivary gland transfer |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Acute Xerostomia | The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements). | Eligible patients who started RT | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to 90 days |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Normal Functioning Transferred Submandibular Gland | Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained. | Eligible patients with salivary scans submitted | Posted | Number | 95% Confidence Interval | percentage of participants | Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire | The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement. | Eligible patients with both baseline and 1-year questionnaire completed | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and one year |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients Experiencing Facial Edema Following Surgery | Facial edema was noted as present or absent following surgery. | Eligible patients who received the procedure | Posted | Number | 95% Confidence Interval | percentage of participants | From surgery to 30 days after surgery |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy | Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy. | Eligible patients who started RT | Posted | Number | 95% Confidence Interval | percentage of participants | From start of radiation therapy to 90 days |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy | Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Late" refers to toxicities occurring at least 91 days from the start of radiation therapy. | Eligible patients who started RT and had toxicity data at least 90 days from the end of RT | Posted | Number | 95% Confidence Interval | percentage of participants | From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Disease-free Survival Rate at 2 Years | Failure was defined as local, regional, or distant recurrence/progression, second primary tumor, or death due to any cause. Disease-free survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Disease-free survival rate is estimated using the kaplan-meier method. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to two years |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival Rate at 2 Years | Failure was defined as death due to any cause. Survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Survival rate is estimated using the kaplan-meier method. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to two years |
|
|
Not provided
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
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 | Surgery + Transfer + Radiation | Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy. | 2 | 44 | 38 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Acute Surgical Complication: Bleeding/hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Cerebral embolism/CVA | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Wound infection | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphatics-Other | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hearing-Other | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Radiation mucositis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Salivary gland disorder NOS | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection NOS | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Esophagus | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Joint | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Larynx | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Mucous Membrane | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Salivary Gland (xerostomia, taste impairme | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Skin (within XRT field) | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Subcutaneous Tissue (Within XRT field) | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rigors | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergy-Other | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood albumin decreased | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Joint, muscle, or bone-Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anxiety NEC | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Insomnia NEC | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sexual/reproductive function-Other | Reproductive system and breast disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary-other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin discoloration | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin-Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Acute Surgical Complication: Facial edema | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Facial edema on the transfer si | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Gland movement out of position | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Neck numbness | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Neck numbness on the transfer s | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Nerve injury: hypoglossal | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Nerve injury: hypoglossal on th | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Nerve injury: lingual | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Other | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Shoulder weakness | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Surgical Complication: Shoulder weakness on the transf | Surgical and medical procedures | Systematic Assessment |
| ||
| Late Surgical Complication: Other | Surgical and medical procedures | Systematic Assessment |
| ||
| Late Surgical Complication: Recurrent adenitis | Surgical and medical procedures | Systematic Assessment |
| ||
| Late Surgical Complication: Submental fullness | Surgical and medical procedures | Systematic Assessment |
| ||
| Edema NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage-Other | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphangiopathy NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radiation Therapy Oncology Group (RTOG) | wseiferheld@acr.org |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011832 | Radiation Injuries |
| D014987 | Xerostomia |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014947 | Wounds and Injuries |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
|
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| Units |
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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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