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The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.
TRIAL DESIGN:
Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer
OBJECTIVES:
Primary
Secondary
TREATMENT PLAN:
Arm A - Induction + chemoradiotherapy
Arm B - Chemoradiotherapy alone
PROJECTED ACCRUAL:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction plus chemoradiotherapy | Active Comparator | Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. |
|
| Chemoradiotherapy | Active Comparator | Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival: Time From Randomization to Death From Any Cause | Survival rates over 6 years. | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause | DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause | Up to 6 years |
| Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Everett Vokes, M.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC University of Southern California Keck School of Medicine | Los Angeles | California | 90033 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Plus Chemoradiotherapy | Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin | Drug | 75 mg/m2 on day 1 |
|
| hydroxyurea | Drug | Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) |
|
| fluorouracil | Drug | 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) |
|
| chemotherapy | Procedure | See protocol for details |
|
| radiotherapy | Procedure | See protocol for details |
|
Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause |
| Up to 6 years |
| Failure Pattern (Local/Regional Recurrence) | Percentage of patients with local/regional recurrence | Up to 6 years |
| Failure Pattern (Distant Recurrence) | Percentage of patients with distant recurrence | Up to 6 years |
| Quality of Life (FACT H&N) | FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| Quality of Life (Normalcy of Diet) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| Quality of Life (Speech) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| Quality of Life (McMaster) | McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| Quality of Life (FACT H&N) | FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function) | Change from baseline to 1 year (1 year-pre) |
| Quality of Life (Normalcy of Diet) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Change from baseline to 1 year (1 year-pre) |
| Quality of Life (Speech) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Change from baseline to 1 year (1 year-pre) |
| Quality of Life (McMaster) | McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function) | Change from baseline to 1 year (1 year-pre) |
| UM Sylvester Comprehensive Cancer Center |
| Miami |
| Florida |
| 33136 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| Joliet Oncology Hematology Associates | Joliet | Illinois | 60435 | United States |
| Fort Wayne Medical Oncology/Hematology Inc. | Fort Wayne | Indiana | 46815 | United States |
| AP&S Clinic, LLC | Terre Haute | Indiana | 47807 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Oncology Care Associates PLLC | Saint Joseph | Michigan | 49085 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | United States |
| Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Tennessee Cancer Institute | Memphis | Tennessee | 38104 | United States |
| UT Health Science Center at San Antonio | San Antonio | Texas | 78258 | United States |
| Oncology Alliance | Milwaukee | Wisconsin | 53215 | United States |
| Clinic of Oncology, University Hospital Center Zagreb | Zagreb | 10000 | Croatia |
| University Hospital for Tumors Zagreb | Zagreb | 10000 | Croatia |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | 22000 | France |
| NN Blokhin Russian Cancer Research Centre RAMS | Moscow | Russia |
| Republican Oncology Dispensary | Ufa | Russia |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| FG001 | Chemoradiotherapy | Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction Plus Chemoradiotherapy | Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details |
| BG001 | Chemoradiotherapy | Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Region of Enrollment | 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 | Overall Survival: Time From Randomization to Death From Any Cause | Survival rates over 6 years. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause | DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause | Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Failure Pattern (Local/Regional Recurrence) | Percentage of patients with local/regional recurrence | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Failure Pattern (Distant Recurrence) | Percentage of patients with distant recurrence | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (FACT H&N) | FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (Normalcy of Diet) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (Speech) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (McMaster) | McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (FACT H&N) | FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to 1 year (1 year-pre) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (Normalcy of Diet) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to 1 year (1 year-pre) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (Speech) | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to 1 year (1 year-pre) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (McMaster) | McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | Posted | Mean | Standard Error | units on a scale | Change from baseline to 1 year (1 year-pre) |
|
6 years
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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 | Induction Plus Chemoradiotherapy | Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details | 39 | 138 | 65 | 138 | 132 | 138 |
| EG001 | Chemoradiotherapy | Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details | 42 | 135 | 38 | 135 | 129 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hemorrhage | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment | C-difficile |
|
| Cardiac stenosis | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cellulitis | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Decreased PO intake | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Edema | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Fatal bleeding | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| General status alteration | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Neutropenic fever | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pulmonary MRI | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Reaction to vancomycin | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pneumopathy | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Positive staph aureus | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Throat pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Tracheostomy placement | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Weakness | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| G-tube complications | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| G-tube placement | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE 3.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment | Hand-foot skin reaction |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Neuropathy motor | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
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| Neuropathy sensory | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
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| Muscle pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 3.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Hemoglobin | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hypoglycemia | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE 3.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE 3.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE 3.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Candidiasis | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Weight loss | Investigations | CTCAE 3.0 | Non-systematic Assessment |
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| Late RT - Esophagus | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment | Late event--after completion of therapy. |
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| Late RT - Larynx | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment | Late event--after completion of therapy. |
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| Late RT - Mucous membrane | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment | Late event--after completion of therapy. |
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| Late RT - Salivary glands | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment | Late event--after completion of therapy. |
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| Late RT - Skin | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
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| Late RT - Anoxrexia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Constipation | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Dry mouth | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Dysphagia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Fatigue | General disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Mucosal inflammation | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Oral pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Pain | General disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
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| Late - Weight loss | Investigations | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
|
| Late - Dysgeusia | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment | Late event--after completion of therapy. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ezra E.W. Cohen | UC San Diego Moores Cancer Center | ecohen@ucsd.edu |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D010255 | Paranasal Sinus Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009669 | Nose Neoplasms |
| D009668 | Nose Diseases |
| D010254 | Paranasal Sinus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D006918 | Hydroxyurea |
| D005472 | Fluorouracil |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
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