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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00074305 | Other Identifier | University of Michigan | |
| R01CA184153 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) |
|
| Boost Arm | Experimental | Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DSF) Time- 2 Year Estimate | Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times. | 2 years post start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional Control Rate | Compare local-regional control rates between the two arms at 1, 2 and 3 years. Local-regional control is defined as the absence of local-regional progression. Locoregional failure (LRF) time was defined as the time from date of diagnosis to local or regional progression. Patients without LRF at last follow-up were censored at date of last follow-up. | 2 years post-treatment |
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Inclusion Criteria:
Patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo-RT, and meet one of the following six criteria:
KPS (Karnofsky Performance Status: A measure of general well being and activities of daily living; scores range from 0 to 100 where 100 represents perfect health) >70 (see Appendix A) within two weeks of enrollment.
Pre-treatment laboratory criteria within four weeks of enrollment:
Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist.
Patients are adults (Age ≥18).
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Mierzwa, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs (VA) Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States | ||
| University of Michigan Hospital |
132 patients were screened resulting in 26 screen failures. 6 patients were enrolled but withdrew from the study before being randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation IMRT (Intensity-Modulated Radiation Therapy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 |
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| Carboplatin | Drug | Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation |
|
| IMRT (Intensity-Modulated Radiation Therapy) | Radiation |
|
| Boost Radiation to Hypoperfused Volumes | Radiation |
|
| Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes | 3 years post treatment |
| Percent of Patients With Adverse Events | Acute and late toxicities will be summarized descriptively by grade and type for each treatment group. The Percent of patients experiencing certain toxicity types will be calculated with score based confidence intervals. Chi-square tests will be used to test whether the proportion of patients with toxicity differs between treatment groups. ACUTE TOXICITIES ≤3MONTHS AFTER RT. LATE TOXICITIES >3MONTHS AFTER RT | 3 years post treatment |
| Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures | Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures | 2 weeks post Radiation Therapy (RT) |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| FG001 | Boost Arm | Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation IMRT (Intensity-Modulated Radiation Therapy) Boost Radiation to Hypoperfused Volumes |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation IMRT (Intensity-Modulated Radiation Therapy) |
| BG001 | Boost Arm | Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation IMRT (Intensity-Modulated Radiation Therapy) Boost Radiation to Hypoperfused Volumes |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Disease Free Survival (DSF) Time- 2 Year Estimate | Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times. | Posted | Median | 90% Confidence Interval | days | 2 years post start of treatment |
|
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| |||||||||||||||||||||||||||||
| Secondary | Local-regional Control Rate | Compare local-regional control rates between the two arms at 1, 2 and 3 years. Local-regional control is defined as the absence of local-regional progression. Locoregional failure (LRF) time was defined as the time from date of diagnosis to local or regional progression. Patients without LRF at last follow-up were censored at date of last follow-up. | Posted | Number | participants | 2 years post-treatment |
| ||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes | Posted | Count of Participants | Participants | 3 years post treatment |
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| ||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients With Adverse Events | Acute and late toxicities will be summarized descriptively by grade and type for each treatment group. The Percent of patients experiencing certain toxicity types will be calculated with score based confidence intervals. Chi-square tests will be used to test whether the proportion of patients with toxicity differs between treatment groups. ACUTE TOXICITIES ≤3MONTHS AFTER RT. LATE TOXICITIES >3MONTHS AFTER RT | Posted | Number | Percent of patients | 3 years post treatment |
| ||||||||||||||||||||||||||||||||
| Secondary | Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures | Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures | This outcome measure was never analyzed; data was not collected and will never be completed. Data is not available now nor will it be available in the future as the data field was not collected during the study by the original study team and the current study team has no information to analyze. | Posted | 2 weeks post Radiation Therapy (RT) |
|
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation IMRT (Intensity-Modulated Radiation Therapy) | 14 | 59 | 15 | 59 | 59 | 59 |
| EG001 | Boost Arm | Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation IMRT (Intensity-Modulated Radiation Therapy) Boost Radiation to Hypoperfused Volumes | 15 | 41 | 12 | 41 | 38 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Fall | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Injury to carotid artery | Injury, poisoning and procedural complications | CTCAE, v.4.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE, v.4.0) | Non-systematic Assessment | anemia and low white blood cells |
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| Mucositis oral | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Oral hemorrhage | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Pain | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Soft tissue infection | Infections and infestations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Tracheitis | Infections and infestations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE, v.4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| dry mouth | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| dry skin | Skin and subcutaneous tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Esophageal pain | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Fat atrophy | Skin and subcutaneous tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Head soft tissue necrosis | Musculoskeletal and connective tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Neck soft tissue necrosis | Musculoskeletal and connective tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Oral pain | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Pain | General disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Salivary duct inflammation | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Skin atrophy | Skin and subcutaneous tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Weight loss | Investigations | CTCAE, v.4.0) | Non-systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Hearing Impaired | Ear and labyrinth disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE, v.4.0) | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE, v.4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
| Jan 29, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2020 | Jan 29, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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