| ID | Type | Description | Link |
|---|---|---|---|
| 05-C-0241 |
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BACKGROUND:
-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.
OBJECTIVES:
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.
ELIGIBILITY:
-This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.
DESIGN:
BACKGROUND:
-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.
OBJECTIVES:
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.
ELIGIBILITY:
DESIGN:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- 5040cGy to the lymph nodes | Experimental | 5040Gray (cGy) to the lymph nodes |
|
| Arm 2 - 5400cGy to the lymph nodes | Experimental | 5400Gray (cGy) to the lymph nodes |
|
| Arm 3 - 5900cGy to the lymph nodes | Experimental | 5900Gray (cGy) to the lymph nodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients) | Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days. | At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy |
| Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3 | Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation. | Completion of Treatment, an average of 8.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria | Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium). |
Not provided
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Pathology report confirming adenocarcinoma of the prostate
Risk of lymph node metastasis greater than or equal to15% as defined by the Partin tables or biopsy proven positive lymph nodes
Tumor visible on magnetic resonance imaging (MRI)
No prior surgery, radiation, or chemotherapy for prostate cancer, with the exception of hormone therapy which may be given neoadjuvantly for up to four (4) months.
Age greater than 18 years old and less than 90 years old.
EXCLUSION CRITERIA:
Cognitively impaired patients who cannot give informed consent.
Patients with metastatic disease beyond the pelvis
Contraindication to biopsy
Contraindication to MRI
Pre-existing and active prostatitis or proctitis
Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin A Camphausen, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12128107 | Background | Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8. | |
| 12743142 | Background |
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6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1- 5040cGy to the Lymph Nodes | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| FG001 | Arm 2 - 5400cGy to the Lymph Nodes | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| FG002 | Arm 3 - 5900cGy to the Lymph Nodes | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1- 5040cGy to the Lymph Nodes | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| BG001 | Arm 2 - 5400cGy to the Lymph Nodes |
| 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 | Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients) | Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days. | 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study. | Posted | Count of Participants | Participants | At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy |
|
Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
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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- 5040cGy to the Lymph Nodes | 5040 Gray (cGy) to the lymph nodes External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Camphausen | National Cancer Institute | 240-760-6205 | camphausen@nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2011 | Oct 3, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2017 | Dec 26, 2018 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
Not provided
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| At median follow-up, approximately 28 months following radiation |
| Number of Participants With a Dose Limiting Toxicity (DLT) | An acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation. | Within 3 months after completion of radiation |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Date treatment consent signed to date off study, approximately 8 years and 3.5 months. |
| Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria | Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage. | At median follow-up, approximately 28 months following radiation |
| Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004. |
| Pt taken off study |
|
| Disease progression on study |
|
| Unable to make a radiation treatment |
|
5400cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
| BG002 | Arm 3 - 5900cGy to the Lymph Nodes | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| BG003 | 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 | Count of Participants | Participants |
|
| Median Prostatic Specific Antigen (PSA) at Diagnosis | Normal PSA is less than 2.5 ng/ml. | Median | Full Range | ng/ml |
|
| Median Gleason Score at Diagnosis | Gleason grading scale helps to evaluate the severity of prostate cancer. A score >8 is a low-grade cancer (less aggressive). A score <8 is a high grade cancer (more aggressive, poor prognosis). | Median | Full Range | scores on a scale |
|
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
|
| Primary | Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3 | Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation. | The MTD of this study was not reached. The original principal investigator left the National Institutes of Health and we are unable to determine why the outcome was not met. | Posted | Completion of Treatment, an average of 8.5 weeks |
|
|
| Secondary | Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria | Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium). | Posted | Count of Participants | Participants | At median follow-up, approximately 28 months following radiation |
|
|
|
| Secondary | Number of Participants With a Dose Limiting Toxicity (DLT) | An acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation. | Posted | Count of Participants | Participants | Within 3 months after completion of radiation |
|
|
|
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 8 years and 3.5 months. |
|
|
|
| Secondary | Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria | Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage. | Posted | Count of Participants | Participants | At median follow-up, approximately 28 months following radiation |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 12 |
| 12 |
| EG001 | Arm 2 - 5400cGy to the Lymph Nodes | 5400cGy to the lymph nodes External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Arm 3 - 5900cGy to the Lymph Nodes | 5900cGy to the lymph nodes External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 0 | 4 | 0 | 4 | 4 | 4 |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Liver | Infections and infestations | CTC (3.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Dermatology/Skin - Other (Penis mass) | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC (3.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Anal lesion - HPV virus (Bx on 1/28/18)) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Diarrhea) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Diarrhea, mucous discharge, abdo pain) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Esophageal cancer) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Urgency, abdominal pain) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (dysuria) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (frequency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (increased bowel frequency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (loose stools; frequency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (mild BRBPR (hemorrhoids stable)) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (moderate diarrhea) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (moderate diarrhea, frequency, mucous) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (moderate frequency, urgency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (rectal bleeding; urgency, frequent watery stools) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Hemorrhage, GI::Rectum | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Hemorrhage, GU::Urinary NOS | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Hot flashes/flushes | Endocrine disorders | CTC (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTC (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTC (3.0) | Systematic Assessment |
|
| Incontinence, anal | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Incontinence, urinary | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTC (3.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Libido | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Mood alteration::Depression | Nervous system disorders | CTC (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Orgasmic dysfunction | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Pain - Other (L shoulder) | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain - Other (R hip) | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain - Other (Thoracic back pain) | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Abdomen NOS | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Breast | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Pelvis | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other (Dribbling) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other (Dysuria) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTC (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTC (3.0) | Systematic Assessment |
|
| Cardiac General - Other (heart murmur) | Cardiac disorders | CTC (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC (3.0) | Systematic Assessment |
|
| Edema: limb | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Endocrine - Other (breast tenderness) | Endocrine disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Incontinence) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (blood streaked stool) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (loose stool, urgency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (loose stools) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (small amount blood in stools) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (urgency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | Infections and infestations | CTC (3.0) | Systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Back | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Joint | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other (Dysuria, Hematuria) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other (nocturia) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTC (3.0) | Systematic Assessment |
|
| Edema: limb | General disorders | CTC (3.0) | Systematic Assessment |
|
| Endocrine - Other (® thyroid size increased) | Endocrine disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (frequency, soft BM's; mild abdo cramping) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Hemorrhage, GU::Urethra | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Extremity-limb | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other (Weak stream) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other (dysuria, nocturia) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTC (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|