Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Carcinogenesis

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Skin Diseases

Precancerous Conditions

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Lidocaine

Ethanol

Subjects at risk of skin cancer (sun-damaged skin) a superficial shave biopsy will be performed.

Subjects without sun-damaged skin a superficial shave biopsy will be performed.

Sample will be obtained from random dorsal forearm skin sites without evidence of keratotic lesions. The site will be selected by the investigator. Skin will first be wiped with an alcohol pad and 1% lidocaine will be superficially infiltrated per standard skin surgical procedures. 30% trichloroacetic acid (TCA, standard chemical peel) will then be applied for five minutes. TCA will be neutralized using bicarbonate. Using a cytology brush (a small brush which is used to collect cells during the course of a biopsy) cells will be collected by gentle scraping surface of the skin. Then, a superficial shave biopsy specimen, obtained by using a dermablade (a flexible, one piece blade specifically designed for shave biopsy and excision of skin lesions) will be obtained.

Superficial shave biopsy

Joan Guitart, MD

The purpose of this study is to correlate pathological features from specimens in order to determine if this new molecular diagnostic technique can be used to detect risk of skin cancer.

Squamous cell carcinoma is the culmination of a multistep carcinogenesis process that is preceded by early stages referred as squamous dysplasia and actinic keratosis. Squamous dysplasia (SD) also known as "field effect" is clinically characterized by xerosis (dry, scaly skin), lentigines and uneven pigmentation. While morphologically skin biopsies and cytology samples show only minimal changes, at the molecular level it is known that SD is characterized by small clone keratinocytes carrying mutations of the P53 gene. An optical technology called Partial Wave Spectroscopy (PWS) probes nanoscale structures in the order of tens to a few hundred nanometers. PWS is a light back-scattering techniques that uses light reflected off of a tissue sample. The measured biomarker is sensitive to the cytosolic and nucleic architecture within the cell and quantifies the nanoscale disorder, which conventional light microscopy fails to appreciate. PWS has allowed to identify various grades of structural disorder at the nanoscale level of colonic and pulmonary premalignant cell samples. Using PWS we aim to study the spectrum of cutaneous SD from patients at high risk for SCC development. Since squamous dysplasia is difficult to assess with routine histology and cytopathology and a grading system for squamous dysplasia by routine histology or cytology is not available, we propose to assess the value of PWS as a new and more sensitive imaging technique. By identifying the degree of SD at the molecular level, we may be able to intervene with close surveillance, early treatment and chemoprevention strategies to achieve lower morbidity by means of fewer and smaller skin cancers.

Nanocytology Test to Evaluate Skin Cancer in High Risk Patients

Nanocytology Evaluation of Epidermal Cells to Assess Risk of Squamous Cell Carcinoma and Field Cancerization in High Risk Patients

The primary outcome measure is to correlate clinical phenotype (age, skin phototype, level of photodamage, history of prior skin cancers) with morphology and nuclear characteristics, in order to determine if this new molecular diagnostic technique can be used to detect early stages of skin carcinogenesis and identify high risk-patients.

Secondary outcome measure is to compare PWS results and clinical phenotype with the evaluation of skin samples by routine cytology/pathology, as they relate to the clinical level of overall photodamaged and prior history of skin cancers.

Northwestern University

After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor, patient will have surgery alone with no hypo fractionation treatment

Surgery + Moderate hypo fractionation (HF) 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.

Surgery + Extreme hypo fractionation (HF): 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed.

After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36).

Adjuvant Radiotherapy:

-Arm B: Surgery followed by moderate hypofractionation RT (15 fractions): 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.

Surgery with additional moderate hypofractionation RT (15 fractions)

Arm A: Surgery alone followed by surveillance

Surgery alone, without radiation post surgery

After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36).

Adjuvant Radiotherapy:

-Arm C= Surgery followed by extreme hypofractionation RT (5 fractions, 2 fractions/week): 30Gy in 5 fractions of 6Gy over 5 weeks to the operative bed.

Surgery with extreme hypo fractionation treatment (HF)

YAZID BELKACEMI, MD, PhD

France GUYOT

Yazid Belkacemi, PhD

Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR).

Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors.

In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction.

In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL.

the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.

A short description, 5000 characters

Intro:

Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR).

Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors.

In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction.

In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL.

Hypothesis/Objective

Main Objective:

To evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.

Primary endpoint:

Local tumor control at 3-year follow-up in a time-to-event analysis Method This is a multicenter, randomized, open-labeled, comparative 3 arms phase III trial.

After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor, all patientsst will have G8 score and a Geriatric Core Data Set (G CODE) evaluation. Performance of a complete oncogeriatric evaluation and its modalities will be left to the discretion of the investigator.

The patients will be randomized in 3 arms with stratification by center, time from surgery to wound healing and perineural invasion.

* Arm A: Surgery alone
* Arm B: Surgery + Moderate HF 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.
* Arm C: Surgery + Extreme HF : 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed.

After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor, the patients will be randomized in 3 arms with stratification by center, time from surgery to wound healing and perineural invasion.

* Arm A: Surgery alone
* Arm B: Surgery + Moderate HF 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.
* Arm C: Surgery + Extreme HF : 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed.

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01

Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT

Acute and late toxicity, as assessed by CTCAE v4.03 criteria

Assistance Publique - Hôpitaux de Paris

Rare Diseases

Carcinoma, Basal Cell

Bowen's Disease

Neoplasms, Basal Cell

Vasoconstrictor Agents

Respiratory System Agents

Dermatologic Agents

Anesthetics

Epinephrine

Anesthetics, Local

Aminolevulinic Acid

Racepinephrine

Epinephryl borate

Methyl 5-aminolevulinate

Sodium Channel Blockers

Diuretics, Potassium Sparing

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Photosensitizing Agents

The treatment starts with a full ablative CO2 laser pretreatment under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with a LED lamp. This treatment is repeated after 14 days.

The treatment starts with a fractional ablative CO2 laser ablation under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with LED lamp. This treatment is repeated after 14 days.

ablation to the level of de dermal papilla

full ablative CO2 laser

180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)

fractional ablative CO2 laser

LED lamp

lidocaine hydrochloride 2% with epinephrine

Barbara Boone, MD PhD

Photodynamic therapy (PDT) is a well established treatment option for superficial non melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD). However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of this photosensitizer. This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Superficial Basal Cell Carcinoma (sBCC) and Bowen Disease (BD) are malignant skin tumors localised in the superficial epidermis. These tumors are highly prevalent in the caucasian population. Diagnosis of sBCC and BD is often delayed because the clinical manifestation may be discrete and lesions are sometimes wrongly diagnosed and treated as eczema. Once the diagnosis is established, the lesions may cover an extensive area, making surgical excision more difficult. At that moment, the physician can make use of less invasive techniques such as photodynamic therapy (PDT). Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of the photosensitizer methyl aminolevulinate (MAL). This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. Ablation of the upper epiderm of the cancer results in an deeper penetration of MAL. Fractional ablation is known to result in better wound healing compared to full ablative CO2 laser ablation, because only small skin columns are ablated instead of the entire epidermal layer. Patients with non operable sBCC or BD lesions covering an area of at least 5 cm2 or with the presence of two small separated lesions, will be investigated. Lesions greater than 5 cm2 are divided in two. After randomization, the half of the lesions will be pretreated with the full ablative CO2 laser, while the other half with the fractional ablative CO2 laser. Afterwards, the entire surface is treated with MAL-PDT. Such as in our current clinical practice, this treatment modality is repeated after a two week interval. Thus, every subject undergoes both treatment modalities, making within-patient comparison possible. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial

A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer

A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.

The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.

The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.

The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.

The aesthetic result is scored by a blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).

The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).

The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).

Patients are asked for their preferred therapy. Following options exist: (1) full ablative CO2 laser + PDT, (2) fractional ablative CO2 laser + PDT, (3) no preference

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nanocytology Test to Evaluate Skin Cancer in High Risk Patients	NCT01905891	Actinic Keratos... Squamous Cell C...	Superficial sha...	18 Years - 89 Years	Northwestern University
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients	NCT05794035	Skin Cancer, No...	Surgery with ad... Surgery alone, ... Surgery with ex...	70 Years -	Assistance Publique - Hôpitaux de Paris
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients	NCT05794035	Skin Cancer, No...	Surgery with ad... Surgery alone, ... Surgery with ex...	70 Years -	Assistance Publique - Hôpitaux de Paris
Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial	NCT03012009	Bowen's Disease Superficial Bas...	full ablative C... fractional abla... MAL LED lamp lidocaine hydro...	18 Years -	University Hospital, Ghent

Spots Global Cancer Trial Database for non melanoma skin cancer