Non-melanoma Skin CancerPhase 2NCT02080962
Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
A Phase 2 study testing 30 Gy in 5 fractions and 40 Gy in 10 fractions in people with Non-melanoma Skin Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer
- What is being tested?
- 30 Gy in 5 fractions and 40 Gy in 10 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Feb 2014
- Phase
- Phase 2
- 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
- Cosmesis not important
- Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation
- Clinical stage I and II
- Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek
- Patient with up to 3 injuries eligible for the study
- Karnofsky Performance Status (KPS) ≥ 70%
- Age > 18 years
- Informed Consent signed by the patient consenting to undergo the study
Who cannot join
- Indian Race
- Prior treatment for their skin cancer
- More than three synchronous lesions to treatment with RT
- Basal syndrome, xeroderma, vitiligo and albinism
- Immunosuppression
- Prior burn at the tumor site
Show all 10Show fewer
- Tumor > 5 cm
- Age <18 years
- Carrier mental incapacity
- People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Barretos Cancer Hospital - Fundacao Pio XII
Barretos, São Paulo, 14784400
About this study
Official title: Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial
Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.
Read the detailed description
Delineation of radiation field
- Gross tumor volume (GTV): disease clinically visible / palpable
- clinical target volume (CTV): equal to GTV
- planned treatment volume (PTV):
- tumors ≤ 2 cm in diameter, with 5-10 mm CTV margin
- tumors> 2-5 cm in diameter, with 15-20 mm CTV margin
- Marking the GTV and PTV pen back projection
- photograph of the treatment area
- protections of the normal structures with blocks of lead, if necessary
Technical
- Distance focus-skin Tube: 35 cm Locator: 30 and 40 cm
- Sizes Tube: 2, 3 and 4 cm in diameter Finder: 6x8 cm, 8x10 cm
- Energy: 80 kV 140 kv
- Filter 80 kV, 2 mm Al 140 kv, 0.5 mm Copper
- Current Draw: 20 mA
Dose
- tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89
- tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Clinical revisions every 5 weekly sessions, or a weekly and at the end of treatment.
- Conditions
- Non-melanoma Skin Cancer
- Being tested
- 30 Gy in 5 fractions, 40 Gy in 10 fractions
- Keywords
- non-melanoma skin cancer, radiotherapy, orthovoltage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 Gy in 5 fractionsRadiation
Also called hypofractionated orthovoltage
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
40 Gy in 10 fractionsRadiation
Also called hypofractionated orthovoltage
tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
| Study group | Role | What they receive |
|---|---|---|
| 30 Gy in 5 fractions of 6 Gy | Experimental | tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89 Receives: Radiation: 30 Gy in 5 fractions |
| 40 Gy in 10 fractions of 4 Gy | Experimental | tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96 Receives: Radiation: 40 Gy in 10 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete remission with hypofractionated RT schemes for NMSC.
RECIST criteria
- Complete Response: disappearance of the lesion
- Partial Response: Reduction ≥ 30% of the larger initial diameter of the lesion
- Progressive Disease: ≥ 20% increase in the largest initial diameter of the lesion
- Stable disease: not increase enough to consider disease progression or reduction sufficient to consider a partial response.
Measured: Second week and twelfth week after initiation of radiotherapy
Secondary outcomes (2)
Quality of Life
EORTC QLQ-C30
Measured: Second week and twelfth week after initiation of radiotherapy
Toxicity
Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Second week and twelfth week after initiation of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Low rate of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo A Nakamura, MD, Principal investigator, Barretos Cancer Hospital - Fundação Pio XII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080962
- Sponsor's protocol ID
- 399/2010
- Status last verified
- Mar 2014
- First submitted
- 3 Feb 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02080962
- Acronym / sponsor ID
- 399/2010
- Conditions
- Non-melanoma Skin Cancer
- Keywords
- non-melanoma skin cancer, radiotherapy, orthovoltage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of recruitment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Mar 2014 (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.
Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.
Detailed description
Delineation of radiation field
- Gross tumor volume (GTV): disease clinically visible / palpable
- clinical target volume (CTV): equal to GTV
- planned treatment volume (PTV):
- tumors ≤ 2 cm in diameter, with 5-10 mm CTV margin
- tumors> 2-5 cm in diameter, with 15-20 mm CTV margin
- Marking the GTV and PTV pen back projection
- photograph of the treatment area
- protections of the normal structures with blocks of lead, if necessary
Technical
- Distance focus-skin Tube: 35 cm Locator: 30 and 40 cm
- Sizes Tube: 2, 3 and 4 cm in diameter Finder: 6x8 cm, 8x10 cm
- Energy: 80 kV 140 kv
- Filter 80 kV, 2 mm Al 140 kv, 0.5 mm Copper
- Current Draw: 20 mA
Dose
- tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89
- tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Clinical revisions every 5 weekly sessions, or a weekly and at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 Gy in 5 fractions of 6 Gy | Experimental | Radiation: 30 Gy in 5 fractionstumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89 |
| 40 Gy in 10 fractions of 4 Gy | Experimental | Radiation: 40 Gy in 10 fractionstumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cosmesis not important
- Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation
- Clinical stage I and II
- Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek
- Patient with up to 3 injuries eligible for the study
Key exclusion criteria (10 listed)
- Indian Race
- Prior treatment for their skin cancer
- More than three synchronous lesions to treatment with RT
- Basal syndrome, xeroderma, vitiligo and albinism
- Immunosuppression
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 |
|---|---|---|
| 30 Gy in 5 fractionsAlso: hypofractionated orthovoltage5 fractions of 600 cGy, once a day, five times a week - TDF: 89 | Radiation | 30 Gy in 5 fractions of 6 Gy |
| 40 Gy in 10 fractionsAlso: hypofractionated orthovoltagetumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96 | Radiation | 40 Gy in 10 fractions of 4 Gy |
Primary outcome
Rate of complete remission with hypofractionated RT schemes for NMSC.
Time frame: Second week and twelfth week after initiation of radiotherapy
RECIST criteria * Complete Response: disappearance of the lesion * Partial Response: Reduction ≥ 30% of the larger initial diameter of the lesion * Progressive Disease: ≥ 20% increase in the largest initial diameter of the lesion * Stable disease: not increase enough to consider disease progression or reduction sufficient to consider a partial response.
2 secondary outcomes
Quality of Life
Time frame: Second week and twelfth week after initiation of radiotherapy
Toxicity
Time frame: Second week and twelfth week after initiation of radiotherapy
Results and safety
The study was stopped early (reason given: Low rate of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
Related trials for Non-melanoma Skin Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitationObservational study
Harvesting Cells for Experimental Cancer Treatments
Melanoma, Gastrointestinal Cancer
RecruitingPhase 1
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Non-Small-Cell Lung, Esophageal Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
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.
Ricardo A Nakamura, MD principal investigator
Barretos Cancer Hospital - Fundação Pio XII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 30 Gy in 5 fractions and 40 Gy in 10 fractions in people with Non-melanoma Skin Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low rate of recruitment.). Results are not available in the source record.
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?
Rate of complete remission with hypofractionated RT schemes for NMSC. (time frame: Second week and twelfth week after initiation of radiotherapy). 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 7 Mar 2014.