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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA021239 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Boston Children's Hospital | OTHER |
| Dana-Farber Cancer Institute |
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The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Beam Radiation | Experimental | Proton Beam Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiation | Radiation | Once per day, 5 days a week for a total of 4 to 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up | Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up. | 5 years from the start of radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced an Acute Toxicity by Grade | Percentage of participants who experienced an acute toxicity following completion of radiation treatment by grade. Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. The recommended evaluation time for acute toxicity after radiotherapy was 6 weeks following completion, but may be at any time during the 3 months after treatment. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torunn Yock, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
Not provided
| Label | URL |
|---|---|
| Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Beam Radiation | Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Proton Beam Radiation | Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient aged 24.6 was granted an exception by the IRB and included in the study despite being over 21. |
| 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 | Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up | Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up. | Posted | Number | 95% Confidence Interval | Percentage of patients | 5 years from the start of radiation treatment |
|
All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment.
Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
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 | Proton Beam Radiation | Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right eye blindness | Eye disorders | CTCAE (3.0) | Systematic Assessment | Grade 4, Unrelated to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torunn Yock, MD | Massachusetts General, Hospital | 6177262000 | tyock@mgh.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| ID | Term |
|---|---|
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| OTHER |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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| 3 months from radiation treatment |
| Dosimetric Comparison | Comparison of dose distribution to tumor and surrounding normal structures using dose volume histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. Percent of normal tissue spared was calculated using the following equation: (100 x (mean x-ray dose - mean proton dose))/mean X-ray dose. No measure of dispersion was calculated for these estimates. The data is no longer available. | 4 years from the start of radiation treatment |
| Local Control | Estimated survival probability (defined as being free of a local recurrence) was calculated using Grays formula for competing risks | 5 years from the start of radiation therapy |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants Who Experienced an Acute Toxicity by Grade | Percentage of participants who experienced an acute toxicity following completion of radiation treatment by grade. Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. The recommended evaluation time for acute toxicity after radiotherapy was 6 weeks following completion, but may be at any time during the 3 months after treatment. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death. | Posted | Count of Participants | Participants | 3 months from radiation treatment |
|
|
|
| Secondary | Dosimetric Comparison | Comparison of dose distribution to tumor and surrounding normal structures using dose volume histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. Percent of normal tissue spared was calculated using the following equation: (100 x (mean x-ray dose - mean proton dose))/mean X-ray dose. No measure of dispersion was calculated for these estimates. The data is no longer available. | Patients who had DVH's generated from proton plans for comparison | Posted | Number | Percentage of normal tissue spared of RT | 4 years from the start of radiation treatment |
|
|
|
|
| Secondary | Local Control | Estimated survival probability (defined as being free of a local recurrence) was calculated using Grays formula for competing risks | Posted | Number | 95% Confidence Interval | percent probability | 5 years from the start of radiation therapy |
|
|
|
|
| 28 |
| 114 |
| 6 |
| 114 |
| 113 |
| 114 |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3, Unrelated to study treatment |
|
| Mood alteration- Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | Grade 4, Unrelated to study treatment |
|
| Infection- Other (Thrush) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 2, Definitely related to study treatment |
|
| Infection- Other (C Diff) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 3. Unrelated to study treatment. |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 4, Unrelated to study treatment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Grade 3. Probably related to study treatment. |
|
| Hearing w/w-o audiogr in monitor prg | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing-other | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Otitis, middle ear (non-infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Otitis, external ear (non-infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing w/o audiogr not in monitor prg | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constitutional, other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Odor (patient odor) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Radiation dermatitis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrophy, Subcutaneous fat | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Induration/fibrosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Athropy, skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chemoradiation dermatitis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Growth hormone secretion abnormality | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Endocrine-other | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gonadotropin secretion abnormality | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste disturbance | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Teeth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Teeth development | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, pharynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Salivary | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fistula, Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Incontinence, anal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ulcer, anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Growth velocity reduction | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Short stature | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Limb length discrepancy | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Puberty, precocious | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alteration in bone age | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Spine kyphosis/lordosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anus, hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rectum, hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection w/ unk ANC conjunctiva | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection w/ unk ANC oral cavity/gums | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection w/ unk ANC sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, conjunctiva | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Edema head and neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphatics-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscular/skeletal hypoplasia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bone: spine-scoliosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic lower extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic facial muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Irritability (children < 3yrs of age) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy CN III pupil/eyelid/extraocul | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurologic-other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy CN VII face-motor / taste | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy CN IX pharynx ear tongue | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Speech impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tearing | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular surface disease | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Eyelid dysfunction | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proptosis/enophthalmos | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Keratitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-photophobia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nystagmus | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Double vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Retinopathy | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Scleral necrosis/melt | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Incontinence urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal/GU-other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sexual/Reproductive function-Other | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vascular-Other (Specify) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vessel injury Carotid | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Throat/pharynx/larynx, pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Oral cavity, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Eye, pain | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Face, pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Middle ear, pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Oral gums, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rectum, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anus, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Buttock, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagus, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| External ear, pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Liver, pain | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ovulatory, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pelvic, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urethra, pain | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vagina, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Title | Measurements |
|---|---|
|
| Maxilla |
|
| <0.01 |
| % pituitary normal tissue spared |
| 73 |
| 2-Sided |
| Other |
| t-test, 2 sided | Paired t-test | <0.01 | % lens (contra) normal tissue spared | 100 | 2-Sided | Other |
| t-test, 2 sided | Paired t-test | 0.02 | % maxilla normal tissue spared | 42 | 2-Sided | Other |