Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium Identifier:
First received: May 10, 2006
Last updated: August 17, 2015
Last verified: August 2015
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anal Cancer
Interventions: Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Radiation: radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Combined Modality Therapy Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab

Participant Flow:   Overall Study
    Combined Modality Therapy  
STARTED     45  
COMPLETED     45  

  Baseline Characteristics
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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.
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Reporting Groups
Combined Modality Therapy cisplatin, 5-flourouruacil, and irradiation plus cetuximab.

Baseline Measures
    Combined Modality Therapy  
Number of Participants  
[units: participants]
[units: years]
Mean (Standard Deviation)
  48.4  (6.7)  
[units: participants]
Female     4  
Male     41  
Ethnicity (NIH/OMB)  
[units: participants]
Hispanic or Latino     7  
Not Hispanic or Latino     37  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     13  
White     28  
More than one race     0  
Unknown or Not Reported     4  
Region of Enrollment  
[units: participants]
United States     45  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Local Failure Rate at 3 Years   [ Time Frame: 3 years following treatment discontinuation ]

2.  Secondary:   Progression-free Survival   [ Time Frame: 1 year ]

3.  Secondary:   Relapse-free Survival   [ Time Frame: 1 year ]

4.  Secondary:   Colostomy-free Survival at 1 Year   [ Time Frame: 1 year ]

5.  Secondary:   Overall Survival   [ Time Frame: 1 year ]

6.  Secondary:   Quality of Life   [ Time Frame: 1 year ]

7.  Secondary:   Toxicity   [ Time Frame: 90 days following treatment discontinuation ]

8.  Secondary:   Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment   [ Time Frame: 1 year following treatment discontinuation ]

9.  Secondary:   Incidence of Opportunistic Illnesses   [ Time Frame: 1 year following treatment discontinuation ]

10.  Secondary:   Objective Response Rate (Complete and Partial)   [ Time Frame: 3 years following treatment discontinuation ]

11.  Secondary:   Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology   [ Time Frame: 6 months following treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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  More Information
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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: Director, AMC Statistical Center
Organization: AMC
phone: 501-526-6712

No publications provided

Responsible Party: AIDS Malignancy Consortium Identifier: NCT00324415     History of Changes
Other Study ID Numbers: AMC-045, U01CA070019, CDR0000440065
Study First Received: May 10, 2006
Results First Received: July 22, 2015
Last Updated: August 17, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Federal Government