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| ID | Type | Description | Link |
|---|---|---|---|
| SU-04272009-2418 | Other Identifier | Stanford University | |
| BRN0010 | Other Identifier | OnCore |
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The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined.
This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).
Brain metastases are the most common intracranial tumors and occur in approximately 25% of patients with cancer. In the US, approximately 170,000 cancer patients a year are diagnosed with brain metastases.
The prognosis of patients with brain metastases is variable and depends on several factors, including performance status, age, control of the primary tumor, and extent of extracranial disease. Historically, patients with brain metastases who receive supportive care only have median survival of 1 to 2 months. However, a subgroup of patients with favorable prognosis who undergo treatment can enjoy an extended life expectancy with median survival of 10 to 16 months. Treatment options for brain metastases include medical management, surgery, and radiation therapy (radiotherapy). Both surgery and radiotherapy have an important role in management of brain metastases, and an optimized treatment plan may include both. It is well-established that surgery followed by conventional whole brain radiation (WBRT) decreases local recurrence and improves median survival compared to WBRT alone. Conventional WBRT is administered as radiotherapy to the whole cranium delivered in 10 to 20 daily treatments.
For this study, radiotherapy will be delivered using stereotactic radiosurgery (SRS) to treat individual metastases. SRS has the advantage of sparing normal brain tissue. In SRS, high energy radiation is precisely directed at the target lesion. Due to the steep fall-off of the radiation dose away from the target, the advantage of relative sparing of the normal brain may be realized. The present study is based on a rationale of treating brain metastases with surgical resection followed by adjuvant SRS to the resection cavity, while deferring conventional WBRT for salvage therapy.
WBRT is associated with a short-term decline in quality of life and long-term deficits in neurocognitive function ("late effects"). Late toxicity of WBRT, such as memory impairment and dementia, is usually irreversible and is likely due to demyelination, vascular damage, and necrosis. Following WBRT, the actuarial rate of neurocognitive toxicity at 2 years can be up to 49%. Recipients of WBRT may demonstrate a > 2 standard deviation decline in their performance at 6 months. Compared to SRS alone, WBRT was reported to be associated with a marked decline in learning and memory function at 4 months (49% vs 23%, in favor of SRS).
To minimize the potential late effects of WBRT, investigators have explored the use of SRS alone, deferring the use of WBRT for salvage treatment if needed. Both retrospective analyses and a prospective randomized trial reported no apparent survival benefit to combining WBRT with SRS compared to SRS alone
Primary Objectives: Determine the maximum tolerated dose (MTD) of stereotactic radiosurgery (SRS).
Secondary Objectives:
Treatment Group assignment will be by SRS dose level. SRS will be administered as 3 fractions. Radiation dose is administered as "Greys" (or "Grays"; abbreviated Gy), a unit by which radiation is measured. Treatment Groups are as follows: Group 1 = 24 Gy (administered as 8 Gy x 3) Group 2 = 7 Gy (9 Gy x 3); Group 3 = 30 Gy (10 Gy x 3); Group 4 = 33 Gy (11 Gy x 3).
Within each Treatment Group, analysis may be stratified by tumor size and suitability for surgical resection, as below. For those participants eligible for surgical resection, the procedure will be conducted in advance of the SRS treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - 24 Grey SRS | Experimental | 24 Grey administered as 8 Gy x 3 fractions |
|
| Arm 2 - 27 Grey SRS | Experimental | 27 Grey administered as 9 Gy x 3 fractions |
|
| Arm 3 - 30 Grey SRS | Experimental | 30 Grey administered as 10 Gy x 3 fractions |
|
| Arm 4 - 33 Grey SRS | Experimental | 33 Grey administered as 11 Gy x 3 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated Stereotactic Radiosurgery (SRS) | Radiation | Standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD) | The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as.
The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Local Disease Control | Local disease control (treatment response) was assessed on the basis of tumor size before and 12 months after treatment. Treatment response was based on the following criteria. Tumor area is determined as the product of 2 measurements of lesion diameter.
Local control is defined as as any treatment response other than progression. The outcome is as the number of participants that did not progress, by radiotherapy dose cohort and tumor size, a number without dispersion. |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Clara Choi | Stanford University | Principal Investigator |
| Scott Soltys | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34670228 | Derived | Rahimy E, Dudley SA, von Eyben R, Pollom EL, Seiger K, Modlin L, Wynne J, Fujimoto D, Jacobs LR, Chang SD, Gibbs IC, Hancock SL, Adler JR, Li G, Choi CYH, Soltys SG. Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases: Health-related Quality of Life Outcomes. Am J Clin Oncol. 2021 Nov 1;44(11):588-595. doi: 10.1097/COC.0000000000000868. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - 24 Grey SRS | 24 Grey administered as 8 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| FG001 | Arm 2 - 27 Grey SRS | 27 Grey administered as 9 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| FG002 | Arm 3 - 30 Grey SRS | 30 Grey administered as 10 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| FG003 | Arm 4 - 33 Grey SRS | 33 Grey administered as 11 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - 24 Grey SRS | 24 Grey administered as 8 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| BG001 | Arm 2 - 27 Grey SRS |
| 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 |
| 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 | Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD) | The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as.
The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD. | There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). | Posted | Number | Dose-limited toxicity (DLT) events | 60 days |
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 | Arm 1 - 24 Grey SRS | 24 Grey administered as 8 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Soltys, Associate Professor of Radiation Oncology | Stanford University | 65072441569 | sgsoltys@stanford.edu |
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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 | Nov 18, 2013 | Dec 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Surgical resection | Procedure | Standard of care |
|
| 12 months |
| Distant Intra-cranial Disease Control | Distant treatment failure (failure to achieve or maintain disease control) is defined as the radiographic appearance of a new or enhancing lesion more than 5 mm from the radiosurgical target volume. The outcome is expressed as the number of participants who have distant treatment failure after radiotherapy dose cohort and tumor size, a number without dispersion. | 12 months |
| Adverse Effects Within 30 Days | Short-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring within 30 days of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. | 30 days |
| Adverse Effects More Than 30 Days up to 1 Year | Long-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring more 30 days but within 12 months of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. | after 30 days and up to 1 year |
| Overall Survival (OS) | Overall survival (OS) is assessed as remaining alive 3 years after stereotactic radiosurgery (SRS) therapy. The outcome is expressed as the number of participants alive 3 years after SRS, by radiotherapy dose cohort and tumor size, a number without dispersion. | 3 years |
| Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30 | Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) survey, a survey of 28 questions with the following responses / numerical values.
| 6 months |
| Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20 | Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20), a survey of 20 questions with the following responses / numerical values.
| 6 months |
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
| BG002 | Arm 3 - 30 Grey SRS | 30 Grey administered as 10 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| BG003 | Arm 4 - 33 Grey SRS | 33 Grey administered as 11 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Arm 1 - 24 Grey SRS | 24 Grey administered as 8 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| OG001 | Arm 2 - 27 Grey SRS | 27 Grey administered as 9 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| OG002 | Arm 3 - 30 Grey SRS | 30 Grey administered as 10 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
| OG003 | Arm 4 - 33 Grey SRS | 33 Grey administered as 11 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care |
|
|
| Secondary | Local Disease Control | Local disease control (treatment response) was assessed on the basis of tumor size before and 12 months after treatment. Treatment response was based on the following criteria. Tumor area is determined as the product of 2 measurements of lesion diameter.
Local control is defined as as any treatment response other than progression. The outcome is as the number of participants that did not progress, by radiotherapy dose cohort and tumor size, a number without dispersion. | There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 12-month treatment response data are included. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Distant Intra-cranial Disease Control | Distant treatment failure (failure to achieve or maintain disease control) is defined as the radiographic appearance of a new or enhancing lesion more than 5 mm from the radiosurgical target volume. The outcome is expressed as the number of participants who have distant treatment failure after radiotherapy dose cohort and tumor size, a number without dispersion. | There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 12-month disease status data are included. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Adverse Effects Within 30 Days | Short-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring within 30 days of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. | There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). | Posted | Number | adverse events | 30 days |
|
|
|
| Secondary | Adverse Effects More Than 30 Days up to 1 Year | Long-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring more 30 days but within 12 months of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. | There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants surviving more than 30 days are included. | Posted | Number | adverse events | after 30 days and up to 1 year |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) is assessed as remaining alive 3 years after stereotactic radiosurgery (SRS) therapy. The outcome is expressed as the number of participants alive 3 years after SRS, by radiotherapy dose cohort and tumor size, a number without dispersion. | There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30 | Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) survey, a survey of 28 questions with the following responses / numerical values.
| There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants providing 6-month European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) health-related quality of life (HR-QoL) data are included. | Posted | Median | Full Range | score on a scale | 6 months |
|
|
|
| Secondary | Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20 | Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20), a survey of 20 questions with the following responses / numerical values.
| There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 6-month European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20) health-related quality of life (HR-QoL) data are included. | Posted | Median | Full Range | score on a scale | 6 months |
|
|
|
| 10 |
| 20 |
| 13 |
| 20 |
| 20 |
| 20 |
| EG001 | Arm 2 - 27 Grey SRS | 27 Grey administered as 9 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care | 6 | 12 | 6 | 12 | 12 | 12 |
| EG002 | Arm 3 - 30 Grey SRS | 30 Grey administered as 10 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care | 5 | 12 | 12 | 12 | 12 | 12 |
| EG003 | Arm 4 - 33 Grey SRS | 33 Grey administered as 11 Gy x 3 fractions Fractionated Stereotactic Radiosurgery (SRS): Standard of care Surgical resection: Standard of care | 5 | 12 | 3 | 12 | 12 | 12 |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Renal and urinary disorders -Others, Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Gastrointestinal disorders-Others, retrosigmoid stent migration to colon wall | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Altered mental status | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain-leg pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Multi-organ failure | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified-Other disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Infection and infectations-other, fever | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Ear and labyrinth disorders-Other, imbalance | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Watering eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Central nervous system necrosis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Eye disorders - Other, diplopia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Tracheal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Eye disorders - Other, visual field loss | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| Title | Measurements |
|---|---|
|
|
|
| Strata B: Small tumor, not resected |
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| Strata C: Large tumor, resected |
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| Strata D: Large tumor, not resected |
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| Strata B: Small tumor, not resected |
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| Strata C: Large tumor, resected |
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| Strata D: Large tumor, not resected |
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| Strata B: Small tumor, not resected |
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| Strata C: Large tumor, resected |
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| Strata D: Large tumor, not resected |
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|
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| Strata B: Small tumor, not resected |
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| Strata C: Large tumor, resected |
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| Strata D: Large tumor, not resected |
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| Strata B: Small tumor, not resected |
|
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| Strata C: Large tumor, resected |
|
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| Strata D: Large tumor, not resected |
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|
|
| Strata B: Small tumor, not resected |
|
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| Strata C: Large tumor, resected |
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| Strata D: Large tumor, not resected |
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| Strata B: Small tumor, not resected |
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| Strata C: Large tumor, resected |
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| Strata D: Large tumor, not resected |
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