Squamous Cell CarcinomaNCT05125354
A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT
An observational study of Squamous Cell Carcinoma and DaRT Treated Patients, run by Alpha Tau Medical LTD. at 2 sites in 2 countries.
Trial summary
Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Squamous Cell Carcinoma, DaRT Treated Patients
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jan 2022to 6 Mar 2022
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The medical records of patients previously treated with Alpha DaRT as part of the completed clinical trial "CTP-SCC-00" will be accessed to follow up with their status, if available.
Who may be able to join
- Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC
- Available information in medical charts and records (electronic or paper)
Who cannot join
- None.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Israel1 site
Davidof Cancer Institution at the Rabin Medical Center Israel
Petah Tikva, 49100
Italy1 site
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola
About this study
Official title: A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy
Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.
Read the detailed description
Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.
Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:
- Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
- Efficacy -
- assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment
- assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment
- assessment of survival status in patients treated with the Alpha DaRT seeds
- Conditions
- Squamous Cell Carcinoma, DaRT Treated Patients
- Keywords
- Squamous Cell Carcinoma, Alpha Radiation
- Medical subject headings
- Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first
Measured: Up to 60 months following DaRT insertion
Adverse Events (AE)
Assessment of late onset of Alpha DaRT related AE
Measured: Up to 60 months following DaRT insertion
Secondary outcomes (2)
Duration of Response
Time from partial or complete response to the first disease progression according to RECIST V1.1
Measured: Up to 60 months following DaRT insertion
Overall Survival (OS)
Time from DaRT insertion to death
Measured: Up to 60 months following DaRT insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start6 Jan 2022
- Primary completion6 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noga Kurman, MD, Principal investigator, Davidof Cancer Institution at Rabin Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125354
- Sponsor's protocol ID
- CTP-SCC-02
- Status last verified
- Oct 2021
- First submitted
- 8 Nov 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy
- ClinicalTrials.gov ID
- NCT05125354
- Acronym / sponsor ID
- CTP-SCC-02
- Conditions
- Squamous Cell Carcinoma, DaRT Treated Patients
- Keywords
- Squamous Cell Carcinoma, Alpha Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 18 Nov 2021 (actual)
- 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.
Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.
Detailed description
Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.
Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:
- Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
- Efficacy -
- assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment
- assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment
- assessment of survival status in patients treated with the Alpha DaRT seeds
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The medical records of patients previously treated with Alpha DaRT as part of the completed clinical trial "CTP-SCC-00" will be accessed to follow up with their status, if available.
Key inclusion criteria (2 listed)
- Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC
- Available information in medical charts and records (electronic or paper)
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 60 months following DaRT insertion
Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first
Adverse Events (AE)
Time frame: Up to 60 months following DaRT insertion
Assessment of late onset of Alpha DaRT related AE
2 secondary outcomes
Duration of Response
Time frame: Up to 60 months following DaRT insertion
Overall Survival (OS)
Time frame: Up to 60 months following DaRT insertion
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 1 Jun 2022.
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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.
Noga Kurman, MD principal investigator
Davidof Cancer Institution at Rabin Medical Center Israel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma and DaRT Treated Patients, run by Alpha Tau Medical LTD. at 2 sites in 2 countries.
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 2 inclusion and 1 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Italy. 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?
Progression Free Survival (PFS) (time frame: Up to 60 months following DaRT insertion). The study lists 2 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 1 Jun 2022.