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This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (36 Gy) | Experimental | 36 Gy in 9 fractions BID x 4 1/2 treatment days |
|
| Cohort 2 (40 Gy) | Experimental | 40 Gy in 10 fractions BID over 5 treatment days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial Breast Irradiation (PBI) | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan | -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her. | Within 1 year of protocol registration |
| Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity | -The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity | Within 1 year of protocol registration |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Cutaneous Toxicity |
| Up to 5 years |
Not provided
Inclusion Criteria
Histologic Documentation:
Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist.
Radiation therapy should begin within:
Age >= 18 years of age
ECOG Performance Status 0-2.
Signed Informed Consent
Exclusion Criteria
The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following criteria should not be entered in this study:
1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region.
b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region.
Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement
Histological evidence of:
History of cosmetic or reconstructive breast surgery
Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.
Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications
Women who are pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Imran Zoberi, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study opened to participant enrollment on 02/14/2006 and closed to participant enrollment on 04/11/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (36 Gy) | 36 Gy in 9 fractions BID x 4 1/2 treatment days Partial Breast Irradiation (PBI) |
| FG001 | Cohort 2 (40 Gy) | 40 Gy in 10 fractions BID over 5 treatment days Partial Breast Irradiation (PBI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (36 Gy) | 36 Gy in 9 fractions BID x 4 1/2 treatment days Partial Breast Irradiation (PBI) |
| BG001 | Cohort 2 (40 Gy) | 40 Gy in 10 fractions BID over 5 treatment days Partial Breast Irradiation (PBI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan | -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her. | Posted | Number | percentage of participants | Within 1 year of protocol registration |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (36 Gy) Acute Toxicities | 36 Gy in 9 fractions BID x 4 1/2 treatment days Partial Breast Irradiation (PBI) Follow toxicities from Day 1 through Day 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Imran Zoberi, M.D. | Washington University School of Medicine | 314-362-8525 | izoberi@radonc.wustl.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Incidence of Breast Fibrosis | Up to 5 years |
| Incidence of Fat Necrosis | -Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat. | Up to 5 years |
| Cosmetic Outcome |
| Up to 5 years |
| Local Control Rate | -Local control rate for this study is the number of participants who remained free of disease in their breast. | Up to 5 years |
| Regional Control Rate | -Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds | Up to 5 years |
| Distant Control Rate | -Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes. | Up to 5 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity | -The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity | Posted | Number | percentage of participants | Within 1 year of protocol registration |
|
|
|
| Secondary | Incidence and Severity of Cutaneous Toxicity |
| 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Incidence of Breast Fibrosis | 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Incidence of Fat Necrosis | -Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat. | 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Cosmetic Outcome |
| 4 patients in Cohort 1 were not evaluable for this outcome measure because 2 patients did not have the cosmetic outcome performed, 1 patient withdrew consent, and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Local Control Rate | -Local control rate for this study is the number of participants who remained free of disease in their breast. | 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Regional Control Rate | -Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds | 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Distant Control Rate | -Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes. | 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| 3 |
| 50 |
| 21 |
| 50 |
| EG001 | Cohort 1 (36 Gy) Late Toxicities | 36 Gy in 9 fractions BID x 4 1/2 treatment days Partial Breast Irradiation (PBI) Follow toxicities from Day 1 through Day 90 | 0 | 50 | 50 | 50 |
| EG002 | Cohort 2 (40 Gy) Acute Toxicities | 40 Gy in 10 fractions BID over 5 treatment days Partial Breast Irradiation (PBI) Follow toxicities from Day 91 through end of follow-up | 0 | 50 | 50 | 50 |
| EG003 | Cohort 2 (40 Gy) Late Toxicities | 40 Gy in 10 fractions BID over 5 treatment days Partial Breast Irradiation (PBI) Follow toxicities from Day 91 through end of follow-up | 0 | 50 | 50 | 50 |
| Infection (mastitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast edema | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Costochondritis | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back/sacral pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast assymmetry | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast function/lactation | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast volume/hypoplasia | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising (in absence of Grade 3/4 thrombocytopenia) | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac conduction abnormality NOS | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest/shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholesterol, serum-high | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema - Nipple/Areolar | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema - breast | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: arm | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: extremity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: trunk | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fibrosis - cosmesis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fibrosis - deep connective tissue | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fibrosis/induration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hair loss/alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes/flushes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection with unknown ANC - bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection with unknown ANC - ungual | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Left ventricular diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Libido | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Limb pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal - stiffness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: balance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: cranial - CN VIII hearing and balance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: cranial - CN VIII sensory-taste | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Orgasmic dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: dermatitis associated with radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Rib tenderness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seroma | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Throat pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Unknown skin - Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Valvular heart disease | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Watery eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Wound complication, non-infectious | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Fair |
|
| Poor |
|