Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Treatment Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's own immune related white blood cells into their tumor would strengthen the immune system to fight against their cancer.
Patients were treated with external beam radiation therapy (EBRT) combined with experimental intratumoral injection of dendritic cell (DC). Patients received 5,040 centigray (cGy) EBRT in 28 equal fractions. Radiation was delivered 5 days per week (Monday-Friday). DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given several days before surgery to assess DC migration. Tumors were surgically resected 3-6 weeks after the completion of EBRT.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBRT + DC Injection + Resection | Experimental | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts as outlined in that intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cell (DC) Injections | Biological |
Group 1 - DC injection # 4 given 24 hours prior to surgery Group 2 - DC injection # 4 given 48 hours prior to surgery Group 3 - DC injection # 4 given 72 hours prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Significant (>/= Grade 2) Toxicity | Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. | Up to 3 years |
| Occurrence of Postoperative Wound Complications |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort | To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this. |
Inclusion Criteria:
Intermediate or high grade sarcoma as determined by pathology review
Musculoskeletal tumor in extremities, trunk or chest wall.
Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter.
Clinical Stage T2N0M0 (AJCC 6th edition)
Patient is not a candidate for neoadjuvant chemotherapy.
Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.
No steroid therapy within 4 weeks of first dendritic cell administration.
No coagulation disorder.
Patient's written informed consent.
No contraindication to resection.
Adequate organ function (measured within a week of beginning treatment).
Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from radiation.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Antonia, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35135810 | Derived | Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382. | |
| 26880867 | Derived | Raj S, Bui MM, Springett G, Conley A, Lavilla-Alonso S, Zhao X, Chen D, Haysek R, Gonzalez R, Letson GD, Finkelstein SE, Chiappori AA, Gabrilovitch DI, Antonia SJ. Long-Term Clinical Responses of Neoadjuvant Dendritic Cell Infusions and Radiation in Soft Tissue Sarcoma. Sarcoma. 2015;2015:614736. doi: 10.1155/2015/614736. Epub 2015 Dec 31. |
Not provided
Not provided
Not provided
Patients with histologically confirmed large high grade soft-tissue sarcomas (STS) of the extremity/trunk/chest wall were enrolled to the study from 5/18/2006 to 2/19/2009. These patients had clinical stage T2N0M0 with a significant (>50%) risk of progressing to distant metastases.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | COHORT 1: EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiation therapy | Procedure | Radiation was delivered 5 days per week (Monday-Friday). |
|
| Complete Resection - Surgery for tumor removal | Procedure | Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
|
Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC). |
| Up to 3 years |
| Participants With No Evidence of Disease at Follow-up | Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years. | 3 years |
| Up to 3 years |
| FG001 | COHORT 2: EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
| FG002 | COHORT 3: EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
| COMPLETED |
|
| NOT COMPLETED |
|
All evaluable participants available for follow-up at time of analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | COHORT 1: EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
| BG001 | COHORT 2: EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
| BG002 | COHORT 3: EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Overall Response Rate (ORR) | Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment. | All evaluable participants available for follow-up at time of analysis. | Posted | Number | participants | Up to 3 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Significant (>/= Grade 2) Toxicity | Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. | All evaluable participants available for follow-up at time of analysis. | Posted | Number | participants | Up to 3 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Postoperative Wound Complications | Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC). | All evaluable participants available for follow-up at time of analysis. | Posted | Number | participants | Up to 3 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Participants With No Evidence of Disease at Follow-up | Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years. | All evaluable participants available for follow-up at time of analysis. | Posted | Number | participants | 3 years |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort | To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this. | Participants evaluable for this measure | Posted | Number | participants | Up to 3 years |
|
|
3 years
All participants
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 | EBRT + DC Injection + Resection | Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only. Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery. Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT. | 5 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound complication, non-infectious - Possibly related | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue, Other - Unrelated | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Dermatology/Skin, Other - Unrelated | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Peripheral arterial ischemia - Unrelated | Vascular disorders | CTC V3 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism - Unrelated | Vascular disorders | CTC V3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Wound - Probably related | Infections and infestations | CTC V3 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatitue | General disorders | CTC V3 | Systematic Assessment |
| |
| Constitutional Symptoms - Other | General disorders | CTC V3 | Systematic Assessment |
| |
| Insomnia | General disorders | CTC V3 | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTC V3 | Systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Other | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Extremity-limb | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Head/headache | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Back | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Joint | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Stomach | General disorders | CTC V3 | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation - Radiation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation - Chemoradiation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Wound complication, non-infectious | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Mood alteration - Anxiety | General disorders | CTC V3 | Systematic Assessment |
| |
| Neurology - Other | General disorders | CTC V3 | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTC V3 | Systematic Assessment |
| |
| Dizziness | General disorders | CTC V3 | Systematic Assessment |
| |
| Mood alteration - Depression | General disorders | CTC V3 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Myositis (inflammation/damage of muscle) | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Lymphatics - Other | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Vision-Blurred vision | Eye disorders | CTC V3 | Systematic Assessment |
| |
| Ocular/Visual - Other | Eye disorders | CTC V3 | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC V3 | Systematic Assessment |
| |
| Allergy/Immunology - other | Immune system disorders | CTC V3 | Systematic Assessment |
| |
| Infection with unknown ANC - Urinary tract NOS | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection with unknown ANC - Wound | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Renal/Genitourinary - Other | Renal and urinary disorders | CTC V3 | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTC V3 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Hot flashes/flushes | Endocrine disorders | CTC V3 | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTC V3 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott J. Antonia, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | 813-745-3883 | scott.antonia@moffitt.org |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
|
|
|
| Counts |
|---|
| Participants |
|
|