Comparative Efficacy of Cemiplimab to Historical Standard of Care in France
Cancer/Squamous Cell Carcinoma of SkinPrimary Objective: -Assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (SOC) with metastatic or locally advanced cutaneous Squamous Cell Carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, on overall survival (OS). Secondary Objectives: Assess Progression Free Survival (PFS) To assess Duration of Response (DOR) To assess Objective Response Rate (ORR) To describe adverse events leading to treatment interruptions and deaths
New Strategies Against Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell CarcinomaThe 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.
State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning...
CarcinomaSquamous Cell of Head and NeckGiven that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations in which proton therapy outperforms conventional photon treatment is needed. The investigators therefore aim to demonstrate through an in silico trial that proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. The same overall treatment time and an equal number of fractions will be used for both treatment modalities wherever possible. The most optimal technique for each individual patient, based on objective criteria related to limiting dose to normal tissue, will be prescribed by the institution concerned for each treatment option.
A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck...
Oropharyngeal Squamous Cell CancerHypopharyngeal Squamous Cell CancerThis study is a phase II trial designed to test the feasibility of delivering IMRT to head and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx), and to assess possible improvement in reducing the incidence of xerostomia with bilateral superficial lobe parotid sparing IMRT.
Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell CarcinomaPatients with advanced head and neck squamous cell carcinoma (HNSCC) may benefit from organ-preservation treatment based on combination of chemotherapy and radiotherapy without compromising disease-free and overall survival. In patients with initially advanced regional disease, there is controversy about the place of routine planned lymph node neck dissection after chemoradiotherapy, especially in responding patients without clinically invaded residual lymph nodes. There is uncertainty about the lymph nodes status after chemoradiation because the structural imaging modalities (CT, MRI) lack sensitivity and specificity : small positive lymph nodes are not detected, and residual large lymph nodes can be sterilized ( " ghosts nodes " with no sign of viable tumor cells at histopathology). Despite the absence of evidence based on prospective study, in numerous institutions currently, head and neck surgeons are quite reluctant to operate on for neck dissection patients with a complete clinical and radiological response following chemoradiation. Metabolic imaging of tumors using PET and the glucose analog FDG has proven effective in head and neck SCC, especially after treatment to differentiate disease progression from radiation-induced inflammation.1 Several studies have shown that the metabolic response could predict the presence or absence of residual tumor cells in the primary tumor as well as the probability of relapse .2-4 Conflicting results have been reported on the use of PET to predict the pathological nodal status after chemoradiation, with negative predictive values ranging from 14 % to 100 %.5,6 Discrepancies observed might be due to the fact that PET was performed at variable time points after the end of radiotherapy. Ideally, PET should be performed as late as possible so that tumor regrowth can begin and become detectable, increasing the sensitivity of the procedure.
Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols
CarcinomaSquamous CellEvidence from laboratory studies suggests that aspirin and tea polyphenols may have an antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this double-blind, randomized controlled clinical trial. Research project is planned to recruit 10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China, which has been known as a high incidence region of ESCC. All the participants receive endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained lesions (USLs). The location and size of each USL will be recorded followed by collecting biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six months and the second at 3 or 5 years later). The primary outcome measure was occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the participants and adverse events.
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma...
Squamous Cell Carcinoma of the Head and NeckThis is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor. For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe. Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional). The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.
MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer...
Cervical AdenocarcinomaCervical Adenosquamous Carcinoma12 moreThis trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx
Squamous Cell Carcinoma of the OropharynxThe curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences. The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).
NCI UNC Project ESCC
Esophageal Squamous Cell CarcinomaBackground: Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the world with high-risk. One of these is in East Africa and include the country of Malawi. Researchers want to learn what factors explain the high risk there so we can understand better what causes this cancer in people everywhere. Objective: To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi because of the large number of cases in that country. Eligibility: Adults at least 18 years old who have ESCC and live in a certain region of Malawi Adults in the same age group and location who do not have ESCC Design: Participants will be screened at a hospital in Malawi. Participants will have a 1-hour interview. They will answer questions about: Demographics (age, ethnicity, education) Place of residence Medical history and family medical history Drug, alcohol, and tobacco use Hot beverage consumption Indoor air pollution Occupation Food habits Farming Gastrointestinal health Participants will have their teeth and fingernails examined. Participants will be asked to give samples of blood, urine, saliva, toenails, and for the cancer cases, a small piece of their tumor. Participants will have 4 phone calls a year for 2 years to ask about their health....