Basal Cell CarcinomaNCT01016899
Electronic Brachytherapy for the Treatment of NMSC
An observational study of Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Xoft, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- electronic brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 187 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2009to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary basal cell and primary squamous cell carcinomas
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cancer Treatment Services - AZ
Casa Grande, Arizona, 85222
Parkridge Medical Center - Sara Cannon Cancer Center
Chattanooga, Tennessee, 37404
Diablo Valley Oncology and Hematology Medical Group
Pleasant Hill, California, 94523
Southwest Oncology Centers
Scottsdale, Arizona, 85251
DCH Cancer Center
Tuscaloosa, Alabama, 35401
About this study
Official title: Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
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.
Read the detailed description
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.
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Being tested
- electronic brachytherapy
- Keywords
- Electronic, Brachytherapy, Nonmelanoma, cancer
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic brachytherapyRadiation
Also called Xoft Axxent System
Post market observational study recording data form patients with skin cancer treated with electronic brachytherapy. Treatment is standard of care, and can vary in dose and fractionation schedule from patient to patient depending on radiation oncologist's judgement for best treatment for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Non-melanoma skin cancer | Early stage squamous or basal cell carcinoma Receives: Radiation: electronic brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence of NMSC
Local recurrence
Measured: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
Secondary outcomes (2)
Cosmetic outcomes for patients treated for NMSC
Cosmetic outcomes
Measured: (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
Occurrence of radiation therapy related skin toxicities
Skin toxicities
Measured: 1, 3, 6 months, and 1, 2, 3, 4, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajay Bhatnagar, MD, MBA, Principal investigator, Cancer Treatment Services-AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016899
- Sponsor's protocol ID
- CTPR-0002
- Status last verified
- Dec 2022
- First submitted
- 13 Nov 2009
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non-melanoma skin cancer. Radiat Oncol. 2010 Sep 28;5:87. doi: 10.1186/1748-717X-5-87.
PubMed 20875139
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
- ClinicalTrials.gov ID
- NCT01016899
- Acronym / sponsor ID
- CTPR-0002
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Keywords
- Electronic, Brachytherapy, Nonmelanoma, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-melanoma skin cancer | – | Radiation: electronic brachytherapyEarly stage squamous or basal cell carcinoma |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary basal cell and primary squamous cell carcinomas
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic brachytherapyAlso: Xoft Axxent SystemPost market observational study recording data form patients with skin cancer treated with electronic brachytherapy. Treatment is standard of care, and can vary in dose and fractionation schedule from patient to patient depending on radiation oncologist's judgement for best treatment for the patient. | Radiation | Non-melanoma skin cancer |
Primary outcome
Local recurrence of NMSC
Time frame: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
Local recurrence
2 secondary outcomes
Cosmetic outcomes for patients treated for NMSC
Time frame: (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
Occurrence of radiation therapy related skin toxicities
Time frame: 1, 3, 6 months, and 1, 2, 3, 4, and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 20875139Bhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non-melanoma skin cancer. Radiat Oncol. 2010 Sep 28;5:87. doi: 10.1186/1748-717X-5-87.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Bhatnagar, MD, MBA principal investigator
Cancer Treatment Services-AZ
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Xoft, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence of NMSC (time frame: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.