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Trial record 10 of 1110 for:    prostate cancer AND radiation

Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00040365
Recruitment Status : Completed
First Posted : June 26, 2002
Results First Posted : March 29, 2012
Last Update Posted : April 30, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Prostatic Neoplasms
Interventions: Drug: Amifostine trihydrate
Radiation: Radiation therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial accrued 30 participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Amifostine
STARTED   30 
Completed Follow Up Phase   19 
COMPLETED   19 
NOT COMPLETED   11 
Death                1 
Progressive disease                7 
Lost to Follow-up                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

Baseline Measures
   Amifostine 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   18 
>=65 years   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.63  (7.06) 
Gender 
[Units: Participants]
 
Female   0 
Male   30 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   3 
Not Hispanic or Latino   27 
Unknown or Not Reported   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   2 
Black   2 
White   23 
Hispanic   3 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures

1.  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.   [ Time Frame: RTOG Acute was used on week 5 and 7 ]

2.  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.   [ Time Frame: The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment. ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 3 years ]

4.  Secondary:   Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)   [ Time Frame: 18 months ]

5.  Secondary:   Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)   [ Time Frame: Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18 ]

6.  Secondary:   Number of Participants Who Had Proctoscopic Examinations   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kevin A. Camphausen
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
phone: 301-496-5457
e-mail: camphauk@mail.nih.gov


Publications of Results:
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.
Menard, C; Camphausen, K; Muanza, T; Crouse, N; Smith, S; Ben-Josef, E; Coleman, C.N. (2003). Intrarectal Ethyol for Radioprotection in Prostate Cancer. Rationale and Early Results. Abstract: 3rd International Cytoprotection Investigator's Congress

Other Publications:

Responsible Party: Kevin A. Camphausen, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00040365     History of Changes
Obsolete Identifiers: NCT00045253
Other Study ID Numbers: 020215
02-C-0215
First Submitted: June 25, 2002
First Posted: June 26, 2002
Results First Submitted: January 13, 2012
Results First Posted: March 29, 2012
Last Update Posted: April 30, 2012