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The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.
The aim is to evaluate the pathological response rate of HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) after de-intensified chemoradiotherapy (CRT). Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. The primary endpoint of this study is the rate of pathological complete response (pCR) after CRT. Longitudinal assessments of quality of life and patient reported outcomes will be obtained prior to, during, and after CRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De-escalated Radiation and Chemotherapy | Experimental | Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity Modulated Radiotherapy (IMRT) | Radiation | All patients will receive IMRT. Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day, respectively. The PTV-HR will include the gross tumor and the PTV-SR will include the lymph nodes at risk for harboring micro-metastatic disease (i.e. subclinical disease). |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). | Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens. | 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened |
| Measure | Description | Time Frame |
|---|---|---|
| Two-Year Local Control | Local control is the arrest of cancer growth at the site of origin. | Median follow-up was 36 months with a range of 5-53 months |
| Regional Control | Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhishamjit Chera, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penrose Cancer Center | Colorado Springs | Colorado | 80907 | United States | ||
| University of Florida, Department of Radiation Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20530316 | Background | Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7. | |
| 28712533 |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study. After the completion of CRT, 1 patient refused the planned surgical evaluation, leaving 43 patients who were fully evaluable.
Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Intervention | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cisplatin | Drug | Cisplatin, 30mg/m2, will be given intravenously over 60 minutes weekly during IMRT; 6 total doses for a total of 180 mg/m2. It is preferred that the doses be administered on days 1, 8, 15, 22, and 29, and 36 of IMRT; however, this is not mandatory. |
|
|
| Limited surgical evaluation | Procedure | 4 to 14 weeks after completion of CRT, patients will have at least a biopsy of the primary tumor and limited neck surgery to remove those lymph nodes that were involved with cancer prior to CRT. |
|
| Median follow-up was 36 months with a range of 5-53 months |
| Cause-Specific Survival | Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC. | The median follow-up was 36 months with a range of 5-53 months |
| Distant Metastases Free Survival | Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread. | the median follow-up was 36 months with a range of |
| Overall Survival Rate | The percentage of participants who are still alive from the start of treatment. | Median follow-up was 36 months with a range of 5-53 months. |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. 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. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms. | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
| The Eating Assessment Tool (EAT-10) Composite Score | The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40. | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
| The Rosenbek Penetration Aspiration Scale | The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject. | Prior to CRT and 4-8 weeks after completion of CRT |
| Gainesville |
| Florida |
| 32610-0385 |
| United States |
| University of North Carolina at Chapel Hill, Department of Radiation Oncology | Chapel Hill | North Carolina | 27599 | United States |
| Rex Healthcare | Raleigh | North Carolina | 27607 | United States |
| Rex Cancer Center of Wakefield | Raleigh | North Carolina | 27614 | United States |
| Mavroidis P, Price A, Fried D, Kostich M, Amdur R, Mendenhall W, Liu C, Das S, Marks LB, Chera B. Dose-volume toxicity modeling for de-intensified chemo-radiation therapy for HPV-positive oropharynx cancer. Radiother Oncol. 2017 Aug;124(2):240-247. doi: 10.1016/j.radonc.2017.06.020. Epub 2017 Jul 13. |
| 26581135 | Derived | Chera BS, Amdur RJ, Tepper J, Qaqish B, Green R, Aumer SL, Hayes N, Weiss J, Grilley-Olson J, Zanation A, Hackman T, Funkhouser W, Sheets N, Weissler M, Mendenhall W. Phase 2 Trial of De-intensified Chemoradiation Therapy for Favorable-Risk Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2015 Dec 1;93(5):976-85. doi: 10.1016/j.ijrobp.2015.08.033. Epub 2015 Aug 22. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study leaving 44 patients included in the baseline characteristics.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | De-escalated Radiation and Chemotherapy | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Marital Status | Count of Participants | Participants |
| ||||||||||||||||||
| Tobacco Use | Count of Participants | Participants |
| ||||||||||||||||||
| Primary Tumor Location | Count of Participants | Participants |
| ||||||||||||||||||
| T Stage | The Classification of Malignant Tumours (TNM) system is the most widely used cancer staging system. The T refers to the size and extent of the main tumor. N refers to the regional lymph nodes. N0 means there is no cancer in nearby lymph nodes. The larger the number following N means the more lymph nodes that contain cancer. | Count of Participants | Participants |
| |||||||||||||||||
| N Stage | The Classification of Malignant Tumours (TNM) system is the most widely used cancer staging system. The T refers to the size and extent of the main tumor. N refers to the regional lymph nodes. N0 means there is no cancer in nearby lymph nodes. The larger the number following N means the more lymph nodes that contain cancer. | Count of Participants | Participants |
| |||||||||||||||||
| HPV/p16 Status | Human papilloma virus (HPV) is a common virus that can cause cancer. p16 is a tumor suppression gene that acts as a cyclin-dependent kinase inhibitor. HPV-related cancers with p16 overexpression (p16+) have a better prognosis than those not related to HPV due to an increased sensitivity to radiotherapy. | 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 | Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). | Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens. | Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated. | Posted | Count of Participants | Participants | 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened |
|
|
| ||||||||||||||||||||||||||
| Secondary | Two-Year Local Control | Local control is the arrest of cancer growth at the site of origin. | Posted | Number | percentage of participants | Median follow-up was 36 months with a range of 5-53 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Regional Control | Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin. | Posted | Number | percentage of participants | Median follow-up was 36 months with a range of 5-53 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Cause-Specific Survival | Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC. | Posted | Number | percentage of participants | The median follow-up was 36 months with a range of 5-53 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Distant Metastases Free Survival | Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread. | Posted | Number | percentage of participants | the median follow-up was 36 months with a range of |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate | The percentage of participants who are still alive from the start of treatment. | Posted | Number | percentage of participants | Median follow-up was 36 months with a range of 5-53 months. |
|
| ||||||||||||||||||||||||||||
| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. 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. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). | Posted | Mean | 95% Confidence Interval | units on a scale | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
| ||||||||||||||||||||||||||||
| Secondary | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms. | Posted | Mean | 95% Confidence Interval | units on a scale | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
| ||||||||||||||||||||||||||||
| Secondary | The Eating Assessment Tool (EAT-10) Composite Score | The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40. | Posted | Mean | 95% Confidence Interval | units on a scale | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
|
| |||||||||||||||||||||||||||
| Secondary | The Rosenbek Penetration Aspiration Scale | The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject. | Posted | Mean | Standard Deviation | units on a scale | Prior to CRT and 4-8 weeks after completion of CRT |
|
4 years
Not provided
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 | Single Intervention | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively | 1 | 45 | 15 | 45 | 40 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Pulmonary embolus/Blood clot |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Bleeding |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Salivary gland infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vagus nerve disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Severely altered eating/swallowing |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Respiratory Infection |
|
Per the protocol, affiliate sites will only report grade 3/4 and all fatal (grade 5) toxicities. 1/2 toxicities were not reported for affiliate sites.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | Robin_V_Johnson@med.unc.edu |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| > 10 Pack Years |
|
| Unknown Primary |
|
| T2 |
|
| T3 |
|
| N2a |
|
| N2b |
|
| N2c |
|
|
|
|
|
|
This data was collected at the first follow-up post-surgery.
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|