View Clinical Trial (Medical Research Study)
Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
| City: |
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Scottsdale |
| State: |
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Arizona |
| Zip Code: |
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85251 |
| Conditions: |
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Basal Cell Carcinoma - Squamous Cell Carcinoma |
| Purpose: |
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The objective of this study is to record recurrence in patients treated for nonmelanoma
(basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic
Brachytherapy System. Additional objectives include evaluate the appearance of the treated
area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic
Brachytherapy System and record the occurrence of radiation therapy related skin changes in
patients treated for nonmelanoma skin cancer.
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| Study Summary: |
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The objective of this study is to record local recurrence in patients treated for
nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent
Electronic Brachytherapy System. Additional objectives include evaluate the cosmetic
outcomes in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic
Brachytherapy System and record the occurrence of radiation therapy related skin toxicities
in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic
Brachytherapy System.
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| Criteria: |
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Inclusion Criteria:
- Patient has signed the informed consent form
- Pathological diagnosis confirmed of squamous cell or basal cell carcinoma
- Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or
Gx (Not assessed in report)
- Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter)
- One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap
between the edges of the lesion margins.
Exclusion Criteria:
- T2 > 4 cm and T3 and T4
- American Joint Committee Staging for NMSC Stages III and IV
- Histopathologic Grade 3 (poorly differentiated) or higher grade
- Target area is adjacent to a burn scar
- Target area is on the lip
- Patient < 50 years of age
- Any prior definitive surgical resection of the cancer
- Perineural invasion
- Lesion depth > 5mm on clinical assessment or as assessed by ultrasound or CT.
- Patient is pregnant (pregnancy test required if standard of care).
- Target area is prone to trauma.
- Target area with compromised lymphatic or vascular drainage.
- Participation in another investigational device or drug study concurrently.
- Patient has undergone prior radiation therapy to this specific anatomic location.
- Patient is receiving pharmacologic agent(s) at or around the time of the Radiation
therapy that is/are known to produce skin reactions that will influence cosmesis
grading during study.
- Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks
after radiation therapy.
- Life expectancy less than five (5) years.
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| NCT ID: |
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NCT01016899 |
| Primary Contact: |
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Principal Investigator
Ajay Bhatnagar, MD, MBA
Cancer Treatment Services-AZ
Michael A Patz, BS, MBA, RAC
Phone: 603-801-1544 ext. 7308
Email: mpatz@icadmed.com
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| Backup Contact: |
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Email: hmatthews@icadmed.com
Heidi M Matthews, BA, CCRA
Phone: 603-801-1544 ext. 7357
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| Location Contact: |
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Scottsdale, Arizona 85251
United States
Mary Grado, RN, MS
Phone: 480-614-6300
Email: ggrado@aol.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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