Carcinoma, Basal CellNCT02939027
Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma
A study testing Electronic Brachytherapy (6,1 Gy) and Electronic Brachytherapy (7 Gy) in people with Carcinoma, Basal Cell, run by Instituto de Investigacion Sanitaria La Fe.
Trial summary
Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Electronic Brachytherapy (6,1 Gy) and Electronic Brachytherapy (7 Gy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jul 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥18 years old.
- Estimated life expectancy of ≥5 years
- Histopathologic diagnosis of early and primary Basal Cell Carcinoma (BCC)
- Clinical stage of BCC: T1 or T2 (by AJCC 2010 criteria, see Table 1)
- Histological subtypes: Superficial BCC or nodular BCC
- Maximum diameter of lesion: 20 mm
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- Maximum depth of invasion: 4 mm.
- Ability to provide informed consent
- Punch biopsy of primary tumor to depth of reticular dermis
Who cannot join
- Men or women <18 years old.
- Estimated life expectancy <5 years.
- BCC that was previously treated (ie, recurrent BCC)
- BCC in region adjacent to or overlapping with region of prior radiotherapy
- BCC on irregular surface (ie, target area not flat)
- BCC adjacent to or overlapping with burn or scar
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- BCC in area prone to trauma
- BCC in area with compromised lymphatic drainage or vascular supply
- Inflammatory process in target area
- Pregnancy or lactation
- Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
- Diabetes that is poorly controlled (Hg A1c >7%)
- Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
- Receipt of treatment with another investigational device or drug
- Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
- Receipt or plan to receive chemotherapy within 6 weeks of radiation therapy
- High likelihood of protocol non-compliance (in opinion of investigator)
About this study
Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment. The objective of ths study will be to determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
Read the detailed description
- Rationale: Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment.
- Objective: To determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
- Study design: Prospective, out-patient based, single centre, single treatment modality
- Study population: 40 patients, >18 years old, having at least 1 BCC. Intervention: BCC will be treated with EBT, using low-energy X-rays. Area of the lesion will be evaluated for tumour presence and size before, during and at 2 weeks, 6 weeks and 3 months after treatment. If the patient has more than one BCC, all of them will be treated with Electronic Brachytherapy but only the largest one will be analysed in the study.
- Main study parameters/endpoints: Local control of BCC.
- Secondary parameters: Acute skin toxicity, skin cosmesis, and care giver satisfaction, and patient satisfaction.
- Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be exposed to low-energy X-rays. Required site-visits are: 1 pretreatment visits (intake/informed consent and biopsy), 6 treatment visits over the course of 2-3 weeks, 6 control-visits 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.
- Patients will also be asked to complete a short questionnaire to evaluate their quality of life.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Electronic Brachytherapy (6,1 Gy), Electronic Brachytherapy (7 Gy)
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Brachytherapy (6,1 Gy)Device
A total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days/week, during 3 weeks or lees, at least 2 days apart each fraction.
Electronic Brachytherapy (7 Gy)Device
A total a dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days/week during 3 weeks or lees, at least 2 days apart each fraction.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | For the first 20 patients, a total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days week, 3 weeks or lees at least 2 days apart each fraction. Receives: Device: Electronic Brachytherapy (6,1 Gy) |
| Group 2 | Experimental | For the next 20 patients a total dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days week 3 weeks or lees at least 2 days apart each fraction. Receives: Device: Electronic Brachytherapy (7 Gy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response of Electronic Brachytherapy
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Measured: 2 weeks after treatment
Clinical Response of Electronic Brachytherapy
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Measured: 6 weeks after treatment
Clinical Response of Electronic Brachytherapy
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Measured: 3 months after treatment
Clinical Response of Electronic Brachytherapy
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Measured: 6 months after treatment
Clinical Response of Electronic Brachytherapy
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Measured: 12 months after treatment
Clinical Response of Electronic Brachytherapy
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Measured: 24 months after treatment
Secondary outcomes (3)
Patient quality of life
Patient quality of life before and after treatment with Esteya Electronic brachytherapy will be measured using the validated Skindex 16 questionnaire. Patient quality of life will be measured before treatment and at 3 months post treatment.
Measured: Before treatment and at 3 months post treatment.
Rate of grade ≥3-4 adverse events
The study will use the EORTC-RTOG and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for assessing toxicity related to brachytherapy. Grade 4 or higher adverse events will be reported, with the exception of grade 4 radiation dermatitis. Grade 5 radiation dermatitis will be reported.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.
Caregiver experience (questionnaire)
User experience with the Esteya electronic brachytherapy device will be measured using the USE Questionnaire (http://hcibib.org/perlman/question.cgi?form=USE). All users of the device will be asked to fill in one questionnaire after their last use of the treatment device. Only one questionnaire will be filled in per user.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939027
- Sponsor's protocol ID
- BCCBrachy
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02939027
- Acronym / sponsor ID
- BCCBrachy
- Conditions
- Carcinoma, Basal Cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Oct 2016 (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.
Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment. The objective of ths study will be to determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
Detailed description
- Rationale: Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment.
- Objective: To determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
- Study design: Prospective, out-patient based, single centre, single treatment modality
- Study population: 40 patients, >18 years old, having at least 1 BCC. Intervention: BCC will be treated with EBT, using low-energy X-rays. Area of the lesion will be evaluated for tumour presence and size before, during and at 2 weeks, 6 weeks and 3 months after treatment. If the patient has more than one BCC, all of them will be treated with Electronic Brachytherapy but only the largest one will be analysed in the study.
- Main study parameters/endpoints: Local control of BCC.
- Secondary parameters: Acute skin toxicity, skin cosmesis, and care giver satisfaction, and patient satisfaction.
- Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be exposed to low-energy X-rays. Required site-visits are: 1 pretreatment visits (intake/informed consent and biopsy), 6 treatment visits over the course of 2-3 weeks, 6 control-visits 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.
- Patients will also be asked to complete a short questionnaire to evaluate their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Electronic Brachytherapy (6,1 Gy)For the first 20 patients, a total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days week, 3 weeks or lees at least 2 days apart each fraction. |
| Group 2 | Experimental | Device: Electronic Brachytherapy (7 Gy)For the next 20 patients a total dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days week 3 weeks or lees at least 2 days apart each fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women ≥18 years old.
- Estimated life expectancy of ≥5 years
- Histopathologic diagnosis of early and primary Basal Cell Carcinoma (BCC)
- Clinical stage of BCC: T1 or T2 (by AJCC 2010 criteria, see Table 1)
- Histological subtypes: Superficial BCC or nodular BCC
Key exclusion criteria (17 listed)
- Men or women <18 years old.
- Estimated life expectancy <5 years.
- BCC that was previously treated (ie, recurrent BCC)
- BCC in region adjacent to or overlapping with region of prior radiotherapy
- BCC on irregular surface (ie, target area not flat)
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 Brachytherapy (6,1 Gy)A total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days/week, during 3 weeks or lees, at least 2 days apart each fraction. | Device | Group 1 |
| Electronic Brachytherapy (7 Gy)A total a dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days/week during 3 weeks or lees, at least 2 days apart each fraction. | Device | Group 2 |
Primary outcome
Clinical Response of Electronic Brachytherapy
Time frame: 2 weeks after treatment
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Clinical Response of Electronic Brachytherapy
Time frame: 6 weeks after treatment
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Clinical Response of Electronic Brachytherapy
Time frame: 3 months after treatment
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Clinical Response of Electronic Brachytherapy
Time frame: 6 months after treatment
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Clinical Response of Electronic Brachytherapy
Time frame: 12 months after treatment
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
Clinical Response of Electronic Brachytherapy
Time frame: 24 months after treatment
Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
3 secondary outcomes
Patient quality of life
Time frame: Before treatment and at 3 months post treatment.
Rate of grade ≥3-4 adverse events
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.
Caregiver experience (questionnaire)
Time frame: 3 weeks
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 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Brachytherapy (6,1 Gy) and Electronic Brachytherapy (7 Gy) in people with Carcinoma, Basal Cell, run by Instituto de Investigacion Sanitaria La Fe.
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 9 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Response of Electronic Brachytherapy (time frame: 2 weeks after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2016.