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Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00060333
First received: May 6, 2003
Last updated: January 30, 2017
Last verified: January 2017
Results First Received: January 30, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Recurrent Melanoma
Intervention: 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
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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
  Description
Treatment (Adjuvant Radiation Therapy) Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.

Participant Flow:   Overall Study
    Treatment (Adjuvant Radiation Therapy)
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  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
  Description
Treatment (Adjuvant Radiation Therapy) Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.

Baseline Measures
   Treatment (Adjuvant Radiation Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Median (Full Range)
 68.0 
 (49.0 to 76.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  50.0% 
Male      10  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures
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1.  Primary:   2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence   [ Time Frame: Within 2 years after treatment ]

2.  Secondary:   Incidence of Regional and Systemic Metastases   [ Time Frame: Up to 5 years ]

3.  Secondary:   Survival Time   [ Time Frame: up to 5 years ]

4.  Secondary:   Failure Time   [ Time Frame: Time from randomization to death due to any cause or disease progression (up to 5 years) ]

5.  Secondary:   Toxicity   [ Time Frame: Up to 5 years ]

6.  Secondary:   Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory   [ Time Frame: Baseline to up to 3 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Barbara A. Pockaj, MD
Organization: Mayo Clinic
phone: 507/284-3559
e-mail: pockaj.barbara@mayo.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00060333     History of Changes
Other Study ID Numbers: NCCTG-N0275
NCI-2009-00641 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000301633 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: May 6, 2003
Results First Received: January 30, 2017
Last Updated: January 30, 2017