| ID | Type | Description | Link |
|---|---|---|---|
| 02-C-0215 |
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This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rectum during radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas.
Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention test, in which they are given an enema of 4 tablespoons of salt water that they must retain for 20 minutes.
Participants will receive standard radiation therapy for prostate cancer-5 consecutive days for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine will be placed in the rectum by a mini-enema before each radiation treatment so that it covers the lining of the rectum. To determine the side effects of the treatment, patients will undergo a proctoscopic examination before beginning radiation therapy, two times during therapy, and at each follow-up visit for 5 years after treatment ends. This examination involves inserting a proctoscope (a thin flexible tube with a light at the end) into the rectum and taking pictures.
Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for a physical examination and routine blood tests, proctoscopic examination, and review of bowel symptoms.
Normal tissue tolerance of the rectum limits the dose of radiation that can be delivered to the prostate for curative treatment of prostate cancer. Amifostine is a radioprotector, an agent that reduces tissue damage incurred by ionizing radiation. It has been well studied in humans and is approved for intravenous use. Rectal administration results in a preferential accumulation of Amifostine in the rectal mucosa, and neither free parent compound nor free active metabolite have been detected in systemic circulation. This trial proposes to observe the rate of early and late bowel toxicity in a group of patients with prostate cancer receiving standard high dose, 3D conformal external beam radiotherapy and concurrent intra-rectal applications of Amifostine. Primary measures of rectal toxicity (RTOG radiation morbidity scoring) will also be compared with self-assessment measures of quality of life, and rectal radiation dose as assessed by dose-volume histograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amifostine | Experimental | 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amifostine trihydrate | Drug | 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer. | A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx | RTOG Acute was used on week 5 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer. | A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx. |
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Pathologically confirmed adenocarcinoma of the prostate gland.
Age greater than or equal to 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
EXCLUSION CRITERIA:
Other active malignancy (except for non-melanoma skin cancer).
Patient with a prior history of pelvic or prostate radiotherapy.
Patients with chronic inflammatory bowel disease.
Patients with distant metastatic disease.
Cognitively impaired patients who cannot give informed consent.
Human Immunodeficiency Virus (HIV) positivity.
Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for high dose 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 |
|---|---|---|---|
| 11577478 | Background | Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15. | |
| 1869452 | Background | Fuks Z, Leibel SA, Wallner KE, Begg CB, Fair WR, Anderson LL, Hilaris BS, Whitmore WF. The effect of local control on metastatic dissemination in carcinoma of the prostate: long-term results in patients treated with 125I implantation. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):537-47. doi: 10.1016/0360-3016(91)90668-t. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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This trial accrued 30 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amifostine | 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amifostine | 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). |
| 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 | Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer. | A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx | Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period. | Posted | Number | Percentage of Participants | RTOG Acute was used on week 5 and 7 |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amifostine | 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain/cramping | Reproductive system and breast disorders | Systematic Assessment | Common Toxicity Criteria (CTC) v2.0 Adverse Event (AE) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin A. Camphausen | National Cancer Institute (NCI), National Institutes of Health (NIH) | 301-496-5457 | camphauk@mail.nih.gov |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004999 | Amifostine |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D014964 | X-Ray Therapy |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
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Not provided
Not provided
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Not provided
Not provided
|
|
| Radiation therapy | Radiation | The treatment will be delivered in at least two phases. The first field reduction will occur after 46Gy and the second field reduction will occur after 70Gy. |
|
|
| The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment. |
| Number of Participants With Adverse Events | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | 3 years |
| Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months) | The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf | 18 months |
| Measures of Quality of Life (QOL)-(Late Follow-up 18 Months) | Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined. | Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18 |
| Number of Participants Who Had Proctoscopic Examinations | Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis. | 3 years |
| 10974469 | Background | Pollack A, Smith LG, von Eschenbach AC. External beam radiotherapy dose response characteristics of 1127 men with prostate cancer treated in the PSA era. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):507-12. doi: 10.1016/s0360-3016(00)00620-9. |
| 17855015 | Result | Simone NL, Menard C, Soule BP, Albert PS, Guion P, Smith S, Godette D, Crouse NS, Sciuto LC, Cooley-Zgela T, Camphausen K, Coleman CN, Singh AK. Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):90-5. doi: 10.1016/j.ijrobp.2007.05.057. Epub 2007 Sep 12. |
| Result | Simone, NL; Soule, BP; Ménard, C; Albert, P; Guion, P; Smith, S; Godette, D; Coleman, CN; Singh, AK. Assessing Rectal Toxicity in a Pilot Study using Intrarectal Amifostine and Concurrent Radiation. 42nd annual meeting of the American society of clinical oncology, Atlanta, GA, June 2006. |
| 14727242 | Result | Menard C, Camphausen K, Muanza T, Sears-Crouse N, Smith S, Ben-Josef E, Coleman CN. Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Semin Oncol. 2003 Dec;30(6 Suppl 18):63-7. doi: 10.1053/j.seminoncol.2003.11.016. |
| 16730138 | Result | Singh AK, Menard C, Guion P, Simone NL, Smith S, Crouse NS, Godette DJ, Cooley-Zgela T, Sciuto LC, Coleman J, Pinto P, Albert PS, Camphausen K, Coleman CN. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1008-13. doi: 10.1016/j.ijrobp.2006.02.030. Epub 2006 May 26. |
| Result | Simone NL, Ménard C, Singh AK, Guion P, Smith S, Crouse NS, Godette D, Cooley-Zgela T, Sciuto LC, Coleman J, Pinto, P, Albert PS, Camphausen K, Coleman CN. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: oral presentation at 91st scientific assembly and annual meeting of the radiological society of North America, Chicago, IL, 2005. |
| 16029787 | Result | Muanza TM, Albert PS, Smith S, Godette D, Crouse NS, Cooley-Zgela T, Sciuto L, Camphausen K, Coleman CN, Menard C. Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1316-21. doi: 10.1016/j.ijrobp.2004.12.083. |
| Medline Plus | View source |
| Drug Information | View source |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Amifostine |
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). |
|
|
| Secondary | Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer. | A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx. | Posted | Number | Percentage of Participants | The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment. |
|
|
|
| Secondary | Number of Participants With Adverse Events | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | Posted | Number | Participants | 3 years |
|
|
|
| Secondary | Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months) | The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf | Posted | Mean | Standard Deviation | scores on a scale | 18 months |
|
|
|
| Secondary | Measures of Quality of Life (QOL)-(Late Follow-up 18 Months) | Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined. | Posted | Mean | Full Range | scores on a scale | Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18 |
|
|
|
| Secondary | Number of Participants Who Had Proctoscopic Examinations | Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis. | Posted | Number | Participants | 3 years |
|
|
|
| 1 |
| 30 |
| 30 |
| 30 |
|
| allergic reaction/hypersensitivity | Immune system disorders | Systematic Assessment | CTCv2.0 AE |
|
| alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| bladder | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| cardiac-ischemia/infarction | Cardiac disorders | Systematic Assessment | CTCv2.0 AE |
|
| chest pain | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| chills | General disorders | Systematic Assessment | CTCv2.0 AE |
|
| CN. VI | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| dysuria | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment | CTCv2.0 AE |
|
| erectile impotence | Reproductive system and breast disorders | Systematic Assessment | CTCv2.0 AE |
|
| erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| fatigue | General disorders | Systematic Assessment | CTCv2.0 AE |
|
| flatulence | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| Genitourinary | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| headache | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| hematochezia | Blood and lymphatic system disorders | Systematic Assessment | CTCv2.0 AE |
|
| hematuria | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| Hot Flashes | Endocrine disorders | Systematic Assessment | CTCv2.0 AE |
|
| hot flashes/flushes | Endocrine disorders | Systematic Assessment | CTCv2.0 AE |
|
| hypotension | Vascular disorders | Systematic Assessment | CTCv2.0 AE |
|
| incontinence | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| injection site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| insomnia | Psychiatric disorders | Systematic Assessment | CTCv2.0 AE |
|
| Knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| libido | Reproductive system and breast disorders | Systematic Assessment | CTCv2.0 AE |
|
| mood alteration- depression | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| mucositis | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| mucous membrane | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| nausea | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| neck/shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| neuropathy-sensory | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| orgasmic dysfunction | Reproductive system and breast disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-weak stream (ibuprofen) | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| other- back (d/t bulge disc (L1-L2P) | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-body hair loss | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-breast tenderness | Reproductive system and breast disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-burning (burning with urination; burning in penis; Cipro) | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-edema (mucosal edema; redness) | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-ejaculate (Cipro) | Reproductive system and breast disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-knee injury (orthopedic evaluation) | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-L arm | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-L side | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-local swelling (r/t IL-2 injection) | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-low back (d/t osteophytes (MRI); Celebrex; Advil) | Musculoskeletal and connective tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-mucositis (erythema) | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-pressure (incr pressure urinary stream) | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-rectal spasm | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-tenesmus | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| other-tubular adenoma (colonoscopy/bx 12/19/05) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | CTCv2.0 AE |
|
| Pain: Headaches | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| palpitations | Cardiac disorders | Systematic Assessment | CTCv2.0 AE |
|
| proctitis | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| radiation dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCv2.0 AE |
|
| sm/ lg bowel | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| syncope | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| taste disturbance | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| thrombosis/embolism | Vascular disorders | Systematic Assessment | CTCv2.0 AE |
|
| Tremor-arms | Nervous system disorders | Systematic Assessment | CTCv2.0 AE |
|
| urinary frequency/urgency | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| urinary retention | Renal and urinary disorders | Systematic Assessment | CTCv2.0 AE |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment | CTCv2.0 AE |
|
| weight gain | General disorders | Systematic Assessment | CTCv2.0 AE |
|
| weight loss | General disorders | Systematic Assessment | CTCv2.0 AE |
|
| Bladder | Renal and urinary disorders | Systematic Assessment | Radiation Therapy Oncology Group (RTOG) Adverse Event (AE) |
|
| Mucous membrane | Skin and subcutaneous tissue disorders | Systematic Assessment | RTOG AE |
|
| Small/large bowel | Gastrointestinal disorders | Systematic Assessment | RTOG AE |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009946 |
| Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
|
| Week 5 bowel bother |
|
| Week 5 RTOG |
|
| Week 7 bowel function |
|
| Week 7 bowel bother |
|
| Week 7 RTOG |
|
| 1 month bowel function |
|
| 1 month bowel bother |
|
| 1 month RTOG |
|
| 3 month bowel function |
|
| 3 month bowel bother |
|
| 3 month RTOG |
|
| 6 month bowel function |
|
| 6 month bowel bother |
|
| 6 month RTOG |
|
| 12 month bowel function |
|
| 12 month bowel bother |
|
| 12 month RTOG |
|
| 18 month bowel function |
|
| 18 month bowel bother |
|
| 18 month RTOG |
|