New Strategies Against Cutaneous Squamous Cell Carcinoma

The gold treatment for local invasive cutaneous squamous cell carcinoma is surgical excision. Nevertheless, surgery is not always an option as a consequence of the age and/or the health status of the patient. One of the objectives of this study is to assess the effects of cisplatin concomitantly with a subsequent low-energy X-rays irradiation in vitro. In order to enhance the effectiveness of this combined treatment, the temporal fractionation of the platinated compound is expected to be performed.

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

human squamous cutaneous carcinoma cell line

Exclusion criteria

contamination

Treatment and study plan

Samples with 2 treatments

Radiation

Study the concomitant effects between chemo- and radiotherapy by means of cellular techniques.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

Hospital Clinic of Barcelona

Registry information

Official study title

Investigation "in Vitro" of New Strategies Alternative to Surgery Against Cutaneous Squamous Cell Carcinoma: Topical Chemotherapy Followed by Superficial Radiotherapy.

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Feb 3, 2016
Registry last updated: Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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