Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The proposed study is a follow-up study to NCT01530997. In NCT01530997, patients with HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) received de-intensified chemoradiotherapy (CRT) followed by a limited surgical evaluation. The primary endpoint of NCT01530997 was the rate of pathological complete response (pCR) after CRT. Power computations were performed for N=40 and were based on the null hypothesis (H0) that the pCR for de-intensified chemoradiotherapy is at least 87%, the historical rate. The type 1 error for this calculation was 14.2%. 43 patients enrolled and 38 were evaluable for the primary endpoint. The observed pCR rate was 89% (34/38). Since the observed pCR rate was excellent in NCT01530997 and was in concordance with the expected rate, in the proposed study we will not mandate a post-CRT surgical evaluation. Instead a PET/CT 10 to 16 weeks post-CRT will be used to determine whether a surgical evaluation is needed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De-escalated Radiation and Chemotherapy | Experimental | Patients will receive Intensity Modulated Radiotherapy Treatments (IMRT), 60 Gy at 2 Gy/fx. The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 total doses. Chemotherapy will not be given to patients with T0-2 N0-1 disease, ≤ 10 pack years smoking history. Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity Modulated Radiotherapy (IMRT) | Radiation | All patients will receive Intensity Modulated Radiotherapy Treatments (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 areas at risk for harboring subclinical microscopic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| 2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment. | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with LC at 2 years post-treatment. | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Colette Shen, MD | University of North Carolina at Chapel Hill, Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| University of North Carolina at Chapel Hill, Department of Radiation Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32017652 | Derived | Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4. | |
| 31411949 |
Not provided
Not provided
115 patients were accrued. One patient voluntarily withdrew prior to treatment. One patient died during treatment secondary to neutropenic sepsis.
Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), Rex Hospital (Raleigh, NC), High Point Regional Health (High Point, NC), and Pardee Memorial Hospital (Hendersonville, NC).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | De-escalated Radiation and Chemotherapy | All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Oct 24, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cisplatin (or alternative) | Drug | Cisplatin is the preferred mandated first choice chemotherapy, however alternative weekly regimens are permissible. Justification for not using cisplatin must be documented. Chemotherapy will be given intravenously weekly during IMRT. 6 total doses will be given. It is preferred that the doses be administered on days 1, 8, 15, 22, 29, and 36; however, this is not mandatory. Chemotherapy will not be given to patients with T0-2 N0-1 disease, ≤ 10 pack years smoking history. |
|
| Assessment for surgical evaluation | Procedure | Decisions for surgical evaluation will be based on the results of the PET/CT 10 to 16 weeks after CRT and clinical exam (including fiberoptic laryngoscopy) at that time. Other optional imaging studies may be performed. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon, with the goal being to remove any suspected residual tumor with a negative resection margin while maintaining organ preservation. This may include biopsies and/or oncological resections of the primary tumor and lymph node metastases. Patients with a negative PET/CT scan will be observed. |
|
| 2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with RC at 2 years post-treatment. | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
| 2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with LRC at 2 years post-treatment. | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
| 2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with DMFS at 2 years post-treatment. | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
| 2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients who are still alive (overall survival) at 2 years post-treatment. | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | United States |
| High Point Regional Health | High Point | North Carolina | 27262 | United States |
| Rex Healthcare | Raleigh | North Carolina | 27607 | United States |
| Derived |
| Chera BS, Amdur RJ, Green R, Shen C, Gupta G, Tan X, Knowles M, Fried D, Hayes N, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Zevallos J, Blumberg J, Patel S, Kasibhatla M, Sheets N, Weissler M, Yarbrough W, Mendenhall W. Phase II Trial of De-Intensified Chemoradiotherapy for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma. J Clin Oncol. 2019 Oct 10;37(29):2661-2669. doi: 10.1200/JCO.19.01007. Epub 2019 Aug 14. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | De-escalated Radiation and Chemotherapy | All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition). |
| 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 | From less to more severe: T0 = No evidence of primary tumor T1 = Tumor 2 cm or less in greatest dimension T2 = Tumor more than 2 cm but not more than 4 cm in greatest dimension T3 = Tumor more than 4 cm in greatest dimension or extension to lingual surface of epiglottis | Count of Participants | Participants |
| |||||||||||||||||
| N Stage (AJCC 7th edition) | From less to more severe: N0 = No regional lymph node metastasis N1 = Metastasis in a single ipsilateral lymph node, 3 cm or less in greatest dimension N2a = Metastasis in a single ipsilateral lymph node more than 3 cm but not more than 6 cm in greatest dimension N2b = Metastasis in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension N2c = Metastasis in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension | Count of Participants | Participants |
| |||||||||||||||||
| N Stage (AJCC 8th edition) | From less to more severe: N0 = No regional lymph node metastasis N1 = One or more ipsilateral lymph nodes, none larger than 6 cm N2 = Contralateral or bilateral lymph nodes, none larger than 6 cm | Count of Participants | Participants |
| |||||||||||||||||
| HPV/p16 Status | 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 | 2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment. | Posted | Count of Participants | Participants | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks) |
|
|
| |||||||||||||||||||||||||||
| Secondary | 2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with LC at 2 years post-treatment. | Posted | Count of Participants | Participants | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
|
| ||||||||||||||||||||||||||||
| Secondary | 2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with RC at 2 years post-treatment. | Posted | Count of Participants | Participants | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
|
| ||||||||||||||||||||||||||||
| Secondary | 2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with LRC at 2 years post-treatment. | Posted | Count of Participants | Participants | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
|
| ||||||||||||||||||||||||||||
| Secondary | 2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients with DMFS at 2 years post-treatment. | Posted | Count of Participants | Participants | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
|
| ||||||||||||||||||||||||||||
| Secondary | 2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | The outcome measure will be reported as the proportion of patients who are still alive (overall survival) at 2 years post-treatment. | Note that the count provided here represents actuarial data and thus does not match the all-cause mortality count in the Adverse Events module. | Posted | Count of Participants | Participants | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). |
|
2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
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 | De-escalated Radiation and Chemotherapy | All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition). | 5 | 114 | 0 | 114 | 59 | 114 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary 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 |
| |
| Aspiration | Respiratory, thoracic and mediastinal 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 |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General 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 |
| |
| Gastric Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition 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 |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system 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 |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colette Shen | University of North Carolina at Chapel Hill | 984-974-0400 | cjshen@email.unc.edu |
| Dec 6, 2024 |
| Prot_SAP_001.pdf |
| 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 |
| D012149 | Restraint, Physical |
| 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 |
| D032763 | Behavior Control |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown |
|
| > 10 pack-years |
|
| Unknown primary |
|
| T2 |
|
| T3 |
|
| N2a |
|
| N2b |
|
| N2c |
|
| N2 |
|
| HPV unknown/p16+ |
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|