- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672254
New Strategies Against Cutaneous Squamous Cell Carcinoma
Investigation "in Vitro" of New Strategies Alternative to Surgery Against Cutaneous Squamous Cell Carcinoma: Topical Chemotherapy Followed by Superficial Radiotherapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cutaneous squamous cell carcinoma (cSCC) accounts for the 20% of the most common skin malignancies, i.e. the non-melanoma skin cancer. cSCC is considered one public health problem because of the high costs of its treatment as cSCC are increasing due to a higher sun exposure, as well as more efficient dermatological examinations. In addition, this kind of skin cancer is characterized by a relatively high risk of metastasis.
The gold standard treatment for local invasive cSCC is based on the surgical excision, leading to a 5-years control rate in low-risk patients of 96%. Nevertheless, surgery for local invasive cSCC is not always an option as a consequence of the age and/or the poor health status of the patient. Therefore, ionizing radiation is used as either primary or adjuvant therapy against cSCC in elderly patients or when surgery would be extremely invasive. Although radiotherapy seem to be a promising option, it needs to be improved in order to damage locally the tumor area, thus avoiding damaging secondary effects on healthy tissues. Typical skin radiation sources are based on superficial, orthovoltage X-rays (XR) beams, as well as electron-beam therapy.
In particular, irradiations of local invasive cSCC by using a superficial XR source at kilovoltage (kV) energy permit a local dose deposition within the tumor volume, with a significant smaller penetration capacity with respect to the higher-energy XR sources. Therefore, kV XR sources become a perfect tool for the treatment of superficial lesions, such as the cSCC. The combination of these keV-energy photons with metallic atoms localized in the tumor would enhance the dose deposited locally in the target, improving thus the therapeutic index of the treatment. Among all the chemotherapeutic options available, platinum-based agents, such as cis-diamminedichloroplatinum (II) (cisplatin or cisPt) has become an essential anti-cancer drug with a substantial therapeutic impact against the most carcinomas-like tumors.
The distortion of the structure of the DNA duplex, converts cisPt in a highly toxic agent per se because of its influence on DNA replication, apoptotic death, and inhibition of the major nuclear repair pathway of cisPt-DNA adducts and radiation-induced DNA breaks. However, dose administration is a key limitation due to the high toxicity of this agent. It is for this reason that the lowest cisPt concentration was used in this study, and the expected effectiveness of cisPt on a cSCC cells were enhanced with a subsequent low-energy XR irradiation in an attempt to explore some new therapeutic strategies against local invasive cSCC.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- human squamous cutaneous carcinoma cell line
Exclusion Criteria:
- contamination
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Shams
Samples without any type of treatment
|
|
Samples with 1 treatment
These samples will be treated with only one therapy: chemical agents such as cisplatin or other metallic compounds, or with superficial radiotherapy.
These results will help us understand the effectiveness of each treatment by itself on cSCC cells.
|
|
Samples with 2 treatments
These samples will be treated with both, chemical agents followed by superficial radiotherapy.
These results will provide us information concerning the effectiveness of both treatments, wich is expected to be enhanced by the concomitant effects.
|
Study the concomitant effects between chemo- and radiotherapy by means of cellular techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study of the effectiveness of each treatment by means of flow cytometry and transmission electron/photon microscopy
Time Frame: 6 months
|
The flow cytometry allows us to analyze the proportion of alive, apoptotic and dead (or necrotic) cells after each treatment, whereas miscroscopy techniques would help us detect cell morphology changes either after chemical agents or X-rays.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study of the effectiveness of both treatments concomitantly by means of flow cytometry and transmission electron/photon microscopy
Time Frame: 6 months
|
The flow cytometry allows us to analyze the proportion of alive, apoptotic and dead (or necrotic) cells after both treatments, whereas miscroscopy techniques would help us detect cell morphology changes (even within the cytoplasm and organelles) after the chemical agents and radiation.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPT-2016.11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous Squamous Cell Carcinoma
-
Replimune Inc.Regeneron PharmaceuticalsActive, not recruitingCutaneous Squamous Cell Carcinoma | Advanced Cutaneous Squamous Cell Carcinoma | Metastatic Cutaneous Squamous Cell CarcinomaSpain, United States, France, Australia, Germany, Canada, Greece, Bulgaria, Italy, Poland
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage...United States
-
Regeneron PharmaceuticalsNot yet recruiting
-
The Netherlands Cancer InstituteRecruitingCutaneous Squamous Cell CarcinomaNetherlands
-
Queen Mary University of LondonActive, not recruiting
-
Fondazione Melanoma OnlusActive, not recruitingCutaneous Squamous Cell CarcinomaItaly
-
H. Lee Moffitt Cancer Center and Research InstituteWithdrawnCutaneous Squamous Cell CarcinomaUnited States
-
Melanoma Institute AustraliaBristol-Myers SquibbNot yet recruitingCutaneous Squamous Cell Carcinoma
-
Shanghai Henlius BiotechRecruitingCutaneous Squamous Cell CarcinomaChina
-
Stanford UniversityGenentech, Inc.Active, not recruitingCutaneous Squamous Cell CarcinomaUnited States
Clinical Trials on Samples with 2 treatments
-
Henan University of Traditional Chinese MedicineUnknown
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosRecruiting
-
Quadram Institute BioscienceEuropean UnionCompleted
-
Goldman, Butterwick, Fitzpatrick and GroffRecruitingImproved Appearance of the Banana Roll RegionUnited States
-
Sahlgrenska University Hospital, SwedenRecruiting
-
Weill Medical College of Cornell UniversityHamad Medical CorporationTerminatedSkeletal DysplasiaQatar
-
Mayo ClinicCompleted
-
Second Affiliated Hospital, School of Medicine,...Unknown
-
Centro Interdisciplinario de Ciencias de la Salud...UnknownPeriodontal Disease "Unrecognized Condition"Mexico
-
University Hospital, CaenUnknown