Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Minimum erythematous dose (DEM) will be calculated using a solar irradiator on the scalp (study area) and on a forearm (control area). On D2 (D1+24h) a solar irradiation corresponding to 2 DEM will be performed on a region of the scalp (studied area), as well as on a forearm (control area). A 3mm biopsy will be performed 15mn after irradiation in these 2 regions to study DNA damage. At D4 (D2+48h) a 2nd biopsy of 3 mm will be performed to study the repair of induced DNA damage. The study of DNA damage induced by UV will be done by immunohistochemical analysis of markers validated in previous studies: CPD=pyridine dimers, 6.4 PP= "6.4 photoproducts", and p53. Immunolabeling will be performed on skin biopsies collected 15 minutes after UV exposure and 48 hours after UV exposure.

the minimum erythematous dose (DEM) will be calculated using a solar irradiator on the scalp (study area) and on a forearm (control area). On D2 (D1+24h) a solar irradiation corresponding to 2 DEM will be performed on a region of the scalp (studied area), as well as on a forearm (control area). A 3mm biopsy will be performed 15mn after irradiation in these 2 regions to study DNA damage. At D4 (D2+48h) a 2nd biopsy of 3 mm will be performed to study the repair of induced DNA damage.

solar irradiation and biopsies

Squamous cell carcinomas (SCC) are the second most common skin cancer in humans. The incidence of SCCs in the USA in 2012 was estimated at 700,000 casesSCCs have a metastatic course in 3% to 5% of cases that is of poor prognosis. In men, the SCCs of the scalp represent the most frequent location of the head and neck, the 3rd location of the whole body. The SCCs of the scalp are more undifferentiated than in other locations. In addition, actinic keratoses of scalp, precursors of SCC, are more resistant to treatment than in other areas. These particularities of the SCCs of the scalp suggest the existence of specific factors at the epidermis level of the scalp.

UV-induced damage to DNA is the defining event in skin photocarcinogenesis. It has already been shown that DNA damage induced by UV and the kinetics of repair of this damage may vary with age or phototype of patients, but the topographic variation of DNA damage has never been studied, although it is known that gene expression in skin cells may differ from one region of the body to another.

the hypothesis is therefore that the particular characteristics of KAs and SCCs at the scal level could be explained by an increased sensitivity to UV-induced damage. It is planned to study UV-induced damage and its repair at the scalp level in humans compared to the forearm.

In Vivo Damage Induced bu UV in the Epidermis of the Scalp

Clinical Study of In Vivo Damage Induced bu UV in the Epidermis of the Scalp

epidermal cells with positive immunolabeling for DNA damage markers (CPD, 6.4PP, p53) count.

Centre Hospitalier Universitaire de Nice

Symptoms and General Pathology

Recurrence

All the enrolled patients were treated with ct-guided radioactive i-125 seed implantation assisted by 3D printing template.Prescription dose 110-130gy.

(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seed implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume;Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc.Regular follow-up was conducted after treatment.

3D-printing Template-assisted CT-guided I-125 Seed Implantation

Zhe Ji, M.D.

Junjie Wang, M.D. Ph.D

The malignant tumor at the thoracic entrance is difficult to be surgically removed, and radiotherapy or radiotherapy based comprehensive treatment is often chosen at the initial diagnosis. However, for patients with recurrence after radiotherapy, there is basically no ideal local treatment.The Radioactive i-125 Seed Implantation (RISI) therapy is characterized by high dose within the tumor target area and low dose to surrounding normal tissues, and its radiation dose rate is low, which theoretically benefits the protection of normal tissues and is more suitable for the salvage treatment of recurrent lesions after radiotherapy.3 d printing template technology is through the advance of the preoperative plan design and optimization, to achieve better avoid endanger organs, template of individualized and human body surface after laminating, registration accuracy, its guide pillar to precise control the direction of the needle, the present data show that in the template with CT guided by solid tumors as well had significantly higher accuracy, as the actual target dose of basic postoperative can reach the design request of the preoperative planning, so the application of 3 d printing template helps to further improve the operation efficiency and safety, also has potential promotion effect to curative effect.

The purpose of this study is: (1) Observe the efficacy, toxicity and side effects of 3d-printed template assisted ct-guided RISI in the treatment of recurrent metastatic squamous cell carcinoma of thoracic inlet lymph node after radiotherapy, and evaluate its safety and effectiveness; (2) to explore the relationship between the efficacy, toxicity and side effects of relapsed metastatic squamous cell carcinoma of thoracic inlet lymph node after radiotherapy with different RISI doses;(3)the related influencing factors affecting the effect/toxicity of RISI in the treatment of relapsed lymph node metastatic squamous cell carcinoma at the thoracic inlet after radiotherapy were analyzed.

This is a non-randomized, prospective, single-arm, cohort study.Patients meeting the inclusion criteria were enrolled successively in the order of admission and treatment.In this study, the dose interval was set as 110-130gy, and a total of 30 patients were expected to be enrolled. The prescription dose was planned to be grouped into 15 patients of 110-120gy and 120-130gy respectively. The specific situation was subject to the actual postoperative verification dose.

Patients meeting the inclusion criteria were enrolled successively in the order of admission and treatment. The dose interval in this study was set as 110-130gy. A total of 30 patients were expected to be enrolled, including 15 patients 110-120gy and 15 patients 120-130gy.

RISI in the Treatment of Recurrent Metastatic SCC of Thoracic Inlet Lymph Nodes

Study on the Safety and Efficacy of 3D-printed Template Assisted Ct-guided RISI in the Treatment of Recurrent Metastatic Squamous Cell Carcinoma of Thoracic Inlet Lymph Nodes After Radiotherapy: a Multi-center Prospective Cohort Study

De-identified individual participant data for all primary and secondary outcome measures will be made available.

The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.

The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.

The time from the date of seeds implantation to the date of death from any cause or the date of last observation.

The time between the beginning of treatment and the progression of the disease or the occurrence of death for any reason.

Peking University Third Hospital

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Squamous Cell Carcinoma of Head and Neck

Skin Neoplasms

Head and Neck Neoplasms

Quality of Life

Patients with high risk cutaneous squamous cell carcinoma of the head-neck area receiving regular, multidisciplinary care.

Patients receiving regular care. In addition, validated questionnaires are administered at two measurement points:

1. after the multidisciplinary consultation, a baseline questionnaire\*, the decision conflict scale and the EQ-5D-5L questionnaire are administered by phone.
2. 1 month after completion of the treatment program (care pathway) the EQ-5D-5L, the BaSQoL and the EORTC IN-PATSAT32 questionnaires will be administered by phone.

Completing the questionnaires takes about 30 minutes each time.

\*Baseline questionnaire: gender, age, marital status, education level, World Health Organization (WHO) performance status, presence of informal care, stage and treatment of cSCC, history of skin cancer, presence of current other skin cancer, and average travel time to hospital.

Regular care with additionally administration of questionnaires

Emmy Cruts, MD

S.F.K. Lubeek, MD, PhD

K Mosterd, MD, PhD

Patient reported outcomes in patients with high-risk cutaneous squamous cell carcinoma in the head-neck region are an important part of the complex care for these patients. Health-related quality of life, decision conflicts in the choice of treatment and satisfaction with care have not yet been sufficiently studied in this patient group.

Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer worldwide after basal cell carcinoma. It involves approximately 20% of all cutaneous malignancies and its incidence is still increasing. In 2020, nearly 15,000 cSCCs were reported in the Netherlands, of which approximately 50% concerned patients aged 75 years or older. UV radiation is the main risk factor for development of a cSCC, therefore the majority of cSCCs are localized to the sun-exposed skin in the head-neck region. cSCCs have a metastatic rate of 2.6-5% and recurrence rate of 1.9-3.7%, with rates increasing in high-risk cSCCs. The increasing incidence, advanced age, the (often) high-risk localization in the head-neck area (given functional and cosmetic importance) and the possible high risk of metastasis result in complex care, especially in stage T2 to T4 cSCCs, also known as high-risk cSCCs.

Patient-reported outcomes and health related quality of life (HRQoL) are important outcomes in the care for high-risk cSCCs in the head-neck region (HNcSCCs). Previous research is limited regarding the impact of cSCCs on QoL in patients with high-risk HNcSCCs , as is research on decision conflicts in the choice of treatment. The PROFILES registry (Arts, 2019) investigated QoL and satisfaction with care in 215 patients with keratinocyte carcinomas in the head-neck region. However, the majority of the patients had basal cell carcinoma (81%); only 23 patients had cSCC. Besides, no distinction was made in high or low risk cSCC. Finally, quality of life and patient satisfaction questionnaires were not administered until at least one year after diagnosis.

Other studies of QoL in cSCC patients do not distinguish stage and/or location of the tumor, involve small study populations, or only use oncological questionnaires rather than disease-specific questionnaires.

In conclusion, there is little scientific research on health related quality of life, decision conflicts in the choice of treatment and satisfaction with care in specific patients with high-risk HNcSCCs.

Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region

Decisional Conflicts, Health-related Quality of Life and Satisfaction With Care in High-risk Cutaneous Squamous Cell Carcinoma in the Head-neck Region: Validated Questionnaires

Decisional conflicts expressed as mean total and domain scores on the Decisional Conflict Scale (DCS) questionnaire.

The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and then multiplying by 25. The total score ranges from 0 to 100. A higher score correlates with a higher decisional conflict.

The 5 domain subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the (3 or 4) items, dividing by the number of items (3 or 4) and then multiplying by 25. The subscores range from 0 to 100 where a higher score correlates with a higher decisional conflict.

Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

HRQoL expressed as mean total/domain scores on the Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire.

The BaSQoL consist of 5 scales: behaviour, diagnosis/treatment, worries, appearance and other people. Items are scored: 0 (not at all), 1 (a little), 2 (quite a bit), 3 (very much). An average score per scale will be calculated (the sum of all scores within one scale, divided by the number of items) resulting in a scale score of 0 to 3. A higher score indicates a higher influence of skin cancer on daily life.

Satisfaction with care expressed as mean total and domain scores on the EORTC IN-PATSAT32 (patient satisfaction) questionnaire.

The EORTC IN-PATSAT32 is composed of 11 multi-item scales (including doctors' and nurses' interpersonal skills, technical skills, information provision and availability, and other hospital personnel kindness/helpfulness and information giving, waiting time and access) and 3 single item scales (including exchange of information, comfort/cleanliness and general satisfaction). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high level of satisfaction with care.

Differences in decisional conflict outcome measures (primary outcome 1) between Maastricht University Medical Center+ and Radboud University Medical Center, expressed as mean total/domain scores on the Decisional Conflict Scale (DCS) questionnaire.

The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and multiplying by 25 (total score range 0-100). A higher score correlates with a higher decisional conflict. The subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the items, dividing by the number of items and multiplying by 25. The subscores range from 0-100; a higher score correlates with a higher decisional conflict.

Differences in health-related quality of life outcome measures (primary outcome 2) between Maastricht University Medical Center+ and Radboud University Medical Center. Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Differences in health-related quality of life outcome measures (primary outcome 3) between Maastricht University Medical Center+ and Radboud University Medical Center. Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Differences in health-related quality of life outcome measures (primary outcome 4) between Maastricht University Medical Center+ and Radboud University Medical Center. HRQoL expressed as mean total/domain scores on the Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire.

The BaSQoL consist of 5 scales: behaviour, diagnosis/treatment, worries, appearance and other people. Items are scored: 0 (not at all), 1 (a little), 2 (quite a bit), 3 (very much). An average score per scale will be calculated (the sum of all scores within one scale, divided by the number of items) resulting in a scale score of 0 to 3. A higher score indicates a higher influence of skin cancer on daily life.

Differences in satisfaction with care outcome measures (primary outcome 5) between Maastricht University Medical Center+ and Radboud University Medical Center. Satisfaction with care expressed as mean total and domain scores on the EORTC IN-PATSAT32 (patient satisfaction) questionnaire.

The EORTC IN-PATSAT32 is composed of 11 multi-item scales (including doctors' and nurses' interpersonal skills, technical skills, information provision and availability, and other hospital personnel kindness/helpfulness and information giving, waiting time and access) and 3 single item scales (including exchange of information, comfort/cleanliness and general satisfaction). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high level of satisfaction with care.

The difference in HRQoL before and after treatment, expressed by mean total and domain scores on the EQ-5D-5L questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Maastricht University Medical Center

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin

Patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin

Reduced Dose Radiation (5600 cGy) dose radiotherapy

Reduced Dose Radiation

Standard Dose Radiation (7000 cGy) dose radiotherapy

Standard Dose Radiation

Marshall Posner, M.D.

This trial aims to directly compare a reduced radiation dose to the standard of care in HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are non-inferior to standard dose CRT.

This is a randomized Phase III study comparing two doses of definitive radiation therapy given with induction and concurrent chemotherapy in HPV-positive oropharynx, unknown primary or nasopharynx cancer. Eligible, consented and registered patients will receive three cycles of Docetaxel Cisplatin and 5-FU (TPF) induction chemotherapy. After 3 cycles, the patients will be assessed for clinical, radiographic and pathologic response to TPF. Patients with a clinical or radiographic CR or PR will be randomized on the second phase of this study, where patients will undergo a 2:1 randomization to reduced (5600 cGy) or standard (7000 cGy) dose radiotherapy with weekly Carboplatin. Patients not meeting the response criteria will be treated with standard dose CRT. Patients not completing 3 cycles TPF for reasons of toxicity, progressive disease, choice, or other medical necessity will be treated with standard dose CRT or surgery depending on their primary site and overall medical condition and followed for survival. Toxicity will be assessed by Symptom scores, QOL and SAE monitoring. The primary end point of the trial is equivalent local regional control and PFS at 3 years. Patients will be followed for 5 years.

The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer

The Quarterback Trial: A Randomized Phase III Clinical Trial Comparing Reduced and Standard Radiation Therapy Doses for Locally Advanced HPV Positive Oropharynx Cancer

randomized trial should not be shared until trial is over.

Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.

Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation.

Overall Survival (OS) 5 years treated with reduced or standard dose CRT.

Number of participants with acute toxicity treated with reduced or standard dose CRT.

To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy.

MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL.

MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed.

A lower or negative score reflects a better quality of life compared to baseline.

XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline.

The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms.

The Biodesign Institute

Arizona State University

Icahn School of Medicine at Mount Sinai

Director, Head and Neck Medical Oncology

Adverse Events were not collected for the pre-randomization phase. Adverse events assessed for participants who were randomized.

Participants received three cycles of Docetaxel, Cisplatin and 5-RU (TPF)

Pre-Randomization

After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin

Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy

Carboplatin: Day 1, every 7 days ( + 2 days)

After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin

Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy

Carboplatin: Day 1, every 7 days ( + 2 days)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Base of Tongue (BOT)

Tonsil

Tumor Site

HPV 16

Other than HPV 16

HPV Status

Never smoker

<10 pack-years

10-20 pack-years

Smoking Status

Dr. Marshall R Posner

at 3 years

at 5 years

Number of Participants With Progression Free Survival (PFS)

Number of Participants With Local-regional Control

Number of Participants With Overall Survival at 5 Years

Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)

Biomarkers Predictive of Failure

Overall Survival at 15 Years

Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.

Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline

MDASI-HN SI

MDASI-HN SS

Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS)

Change in Xerostomia Questionnaire (XQ)

EORTC GHS

EORTC FS

EORTC SS

EORTC HN

Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN)

Pre Randomization

Randomization

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

Sunscreening Agents

Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).

Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).

Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

MD-3511356

Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

Standard Sun Protection Measures

Claas Ulrich, MD

The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.

The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.

Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients

Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations

Spirig Pharma Ltd.

Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).

Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).

MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

Trial was terminated early for futility reasons (outcome would not be changed, if trial pursued up completion) and potential "loss of chance" (which could neither be confirmed nor rejected at the time) for patients included in the MD 3511356 group.

Dr. Francine Santoro

241 patients were randomized: 160 to the MD 3511356 group and 81 to the standard care group. All 241 randomized patients received at least one dose of trial device and therefore were all included in the safety population. The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.

Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas

The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.

For patient 10018 (MD-3511356 group) the age of first organ transplant was not computable due to missing date.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vivo Damage Induced bu UV in the Epidermis of the Scalp	NCT04142489	Squamous Cell C...	solar irradiati...	40 Years - 60 Years	Centre Hospitalier Universitaire de Nice
RISI in the Treatment of Recurrent Metastatic SCC of Thoracic Inlet Lymph Nodes	NCT04266327	Brachytherapy Squamous Cell C...	3D-printing Tem...	18 Years - 75 Years	Peking University Third Hospital
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer	NCT01706939	Squamous Cell C...	Reduced Dose Ra... Standard Dose R... Carboplatin	18 Years -	Icahn School of Medicine at Mount Sinai
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer	NCT01706939	Squamous Cell C...	Reduced Dose Ra... Standard Dose R... Carboplatin	18 Years -	Icahn School of Medicine at Mount Sinai
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
In Vivo Damage Induced bu UV in the Epidermis of the Scalp	NCT04142489	Squamous Cell C...	solar irradiati...	40 Years - 60 Years	Centre Hospitalier Universitaire de Nice
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer	NCT01706939	Squamous Cell C...	Reduced Dose Ra... Standard Dose R... Carboplatin	18 Years -	Icahn School of Medicine at Mount Sinai
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients	NCT01532453	Actinic Keratos... Squamous Cell C...	MD-3511356 Standard Sun Pr...	40 Years -	Spirig Pharma Ltd.

Spots Global Cancer Trial Database for squamous cell carcinomas