Trial Outcomes & Findings for Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer (NCT NCT00040365)
NCT ID: NCT00040365
Last Updated: 2012-04-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
RTOG Acute was used on week 5 and 7
Results posted on
2012-04-30
Participant Flow
This trial accrued 30 participants.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Completed Follow Up Phase
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Progressive disease
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Amifostine
n=30 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
65.63 years
STANDARD_DEVIATION 7.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: RTOG Acute was used on week 5 and 7Population: Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period.
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
Outcome measures
| Measure |
Amifostine
n=29 Participants
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).
|
|---|---|
|
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.
|
20.69 Percentage of Participants
|
SECONDARY outcome
Timeframe: The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.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.
Outcome measures
| Measure |
Amifostine
n=6 Participants
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).
|
|---|---|
|
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.
|
83.33 Percentage of Participants
|
SECONDARY outcome
Timeframe: 3 yearsHere are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Amifostine
n=30 Participants
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).
|
|---|---|
|
Number of Participants With Adverse Events
|
30 Participants
|
SECONDARY outcome
Timeframe: 18 monthsThe 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
Outcome measures
| Measure |
Amifostine
n=30 Participants
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).
|
|---|---|
|
Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)
|
0.6 scores on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18Radiation 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.
Outcome measures
| Measure |
Amifostine
n=30 Participants
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).
|
|---|---|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Baseline bowel function
|
91.13 scores on a scale
Interval 71.43 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Baseline bowel bother
|
92.86 scores on a scale
Interval 67.86 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Week 5 bowel function
|
71.43 scores on a scale
Interval 39.29 to 96.43
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Week 5 bowel bother
|
67.33 scores on a scale
Interval 28.57 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Week 5 RTOG
|
1.06 scores on a scale
Interval 0.0 to 2.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Week 7 bowel function
|
69.76 scores on a scale
Interval 32.14 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Week 7 bowel bother
|
66.38 scores on a scale
Interval 21.43 to 96.43
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Week 7 RTOG
|
1.00 scores on a scale
Interval 0.0 to 2.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
1 month bowel function
|
84.09 scores on a scale
Interval 42.86 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
1 month bowel bother
|
78.08 scores on a scale
Interval 32.14 to 96.43
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
1 month RTOG
|
0.59 scores on a scale
Interval 0.0 to 1.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
3 month bowel function
|
79.08 scores on a scale
Interval 46.43 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
3 month bowel bother
|
82.78 scores on a scale
Interval 17.86 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
3 month RTOG
|
0.54 scores on a scale
Interval 0.0 to 2.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
6 month bowel function
|
85.46 scores on a scale
Interval 50.0 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
6 month bowel bother
|
81.86 scores on a scale
Interval 50.0 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
6 month RTOG
|
0.39 scores on a scale
Interval 0.0 to 1.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
12 month bowel function
|
83.92 scores on a scale
Interval 39.29 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
12 month bowel bother
|
77.65 scores on a scale
Interval 10.71 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
12 month RTOG
|
0.50 scores on a scale
Interval 0.0 to 2.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
18 month bowel function
|
83.55 scores on a scale
Interval 50.0 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
18 month bowel bother
|
76.28 scores on a scale
Interval 14.29 to 100.0
|
|
Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
18 month RTOG
|
0.64 scores on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 3 yearsProctoscopic 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.
Outcome measures
| Measure |
Amifostine
n=30 Participants
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).
|
|---|---|
|
Number of Participants Who Had Proctoscopic Examinations
|
30 Participants
|
Adverse Events
Amifostine
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amifostine
n=30 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Proctitis
|
3.3%
1/30 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Amifostine
n=30 participants at risk
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).
|
|---|---|
|
Reproductive system and breast disorders
abdominal pain/cramping
|
13.3%
4/30 • Number of events 5 • 3 years
|
|
Immune system disorders
allergic reaction/hypersensitivity
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
alopecia
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
16.7%
5/30 • Number of events 6 • 3 years
|
|
Renal and urinary disorders
bladder
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Cardiac disorders
cardiac-ischemia/infarction
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
chest pain
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
General disorders
chills
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
CN. VI
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
diarrhea
|
83.3%
25/30 • Number of events 42 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
dry skin
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
13.3%
4/30 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
dysuria
|
53.3%
16/30 • Number of events 24 • 3 years
|
|
Reproductive system and breast disorders
erectile dysfunction
|
10.0%
3/30 • Number of events 3 • 3 years
|
|
Reproductive system and breast disorders
erectile impotence
|
60.0%
18/30 • Number of events 24 • 3 years
|
|
Skin and subcutaneous tissue disorders
erythema
|
10.0%
3/30 • Number of events 3 • 3 years
|
|
General disorders
fatigue
|
90.0%
27/30 • Number of events 48 • 3 years
|
|
Gastrointestinal disorders
flatulence
|
30.0%
9/30 • Number of events 9 • 3 years
|
|
Renal and urinary disorders
Genitourinary
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
headache
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
hematochezia
|
20.0%
6/30 • Number of events 7 • 3 years
|
|
Renal and urinary disorders
hematuria
|
13.3%
4/30 • Number of events 5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Endocrine disorders
Hot Flashes
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Endocrine disorders
hot flashes/flushes
|
16.7%
5/30 • Number of events 10 • 3 years
|
|
Vascular disorders
hypotension
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
incontinence
|
76.7%
23/30 • Number of events 34 • 3 years
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Psychiatric disorders
insomnia
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Knee
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
libido
|
20.0%
6/30 • Number of events 6 • 3 years
|
|
Nervous system disorders
mood alteration- depression
|
73.3%
22/30 • Number of events 34 • 3 years
|
|
Gastrointestinal disorders
mucositis
|
66.7%
20/30 • Number of events 29 • 3 years
|
|
Gastrointestinal disorders
mucous membrane
|
63.3%
19/30 • Number of events 28 • 3 years
|
|
Gastrointestinal disorders
nausea
|
10.0%
3/30 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
neck/shoulder
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
neuropathy-sensory
|
10.0%
3/30 • Number of events 4 • 3 years
|
|
Reproductive system and breast disorders
orgasmic dysfunction
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
other-weak stream (ibuprofen)
|
66.7%
20/30 • Number of events 32 • 3 years
|
|
Musculoskeletal and connective tissue disorders
other- back (d/t bulge disc (L1-L2P)
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
other-body hair loss
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
other-breast tenderness
|
10.0%
3/30 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
other-burning (burning with urination; burning in penis; Cipro)
|
3.3%
1/30 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
other-edema (mucosal edema; redness)
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
other-ejaculate (Cipro)
|
10.0%
3/30 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
other-knee injury (orthopedic evaluation)
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
other-L arm
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
other-L side
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
other-local swelling (r/t IL-2 injection)
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
other-low back (d/t osteophytes (MRI); Celebrex; Advil)
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
other-mucositis (erythema)
|
6.7%
2/30 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
other-pressure (incr pressure urinary stream)
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
other-rectal spasm
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
other-tenesmus
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
other-tubular adenoma (colonoscopy/bx 12/19/05)
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
Pain: Headaches
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Cardiac disorders
palpitations
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
proctitis
|
96.7%
29/30 • Number of events 89 • 3 years
|
|
Skin and subcutaneous tissue disorders
pruritis
|
26.7%
8/30 • Number of events 9 • 3 years
|
|
Skin and subcutaneous tissue disorders
radiation dermatitis
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
sm/ lg bowel
|
93.3%
28/30 • Number of events 89 • 3 years
|
|
Nervous system disorders
syncope
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
taste disturbance
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Vascular disorders
thrombosis/embolism
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Nervous system disorders
Tremor-arms
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
urinary frequency/urgency
|
90.0%
27/30 • Number of events 57 • 3 years
|
|
Renal and urinary disorders
urinary retention
|
70.0%
21/30 • Number of events 36 • 3 years
|
|
Gastrointestinal disorders
vomiting
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
General disorders
weight gain
|
43.3%
13/30 • Number of events 20 • 3 years
|
|
General disorders
weight loss
|
36.7%
11/30 • Number of events 11 • 3 years
|
|
Renal and urinary disorders
Bladder
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Mucous membrane
|
63.3%
19/30 • Number of events 28 • 3 years
|
|
Gastrointestinal disorders
Small/large bowel
|
93.3%
28/30 • Number of events 89 • 3 years
|
Additional Information
Kevin A. Camphausen
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-496-5457
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place