Patient Preferences in Making Treatment Decisions in Patients With Stage I-IVA Oropharyngeal Cancer...
Stage I Squamous Cell Carcinoma of the OropharynxStage II Squamous Cell Carcinoma of the Oropharynx3 moreThis pilot research trial studies patient preferences in making treatment decisions in patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient priorities before and after treatment may improve the ability to plan for better quality of life in patients with oropharyngeal cancer.
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy...
Oral Squamous Cell CarcinomaSquamous Cell Carcinoma of Oropharynx2 moreThe purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.
An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic...
Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckOne promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST version 1.1.
Reactivating NK Cells in Treating Refractory Head and Neck Cancer
Nasopharyngeal CancerHead and Neck Squamous Cell CarcinomaThis study aims to determine the safety and efficacy of expanded activated autologous NK cells administered after cetuximab in patients with EGFR-positive nasopharyngeal carcinoma or head and neck squamous cell carcinoma.
Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal...
Esophageal Squamous Cell CarcinomaThe primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.
Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
Esophageal Squamous Cell CancerNimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.
Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab...
Squamous Cell Carcinoma of the Head and NeckPrimary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy. Secondary To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and neck the following study variables between both treatment arms: Best overall response Duration of response Time to treatment failure Overall survival Safety
Durvalumab Plus Tremelimumab Combined With Proton Therapy for HNSCC
Head and Neck Squamous Cell CarcinomaClinical Phase: phase II single arm study Primary Objectives: Response rate Number of Subjects: 27 patients Study Population: recurrent or metastatic head and neck squamous cell carcinoma Investigational Product(s), Dose, and Mode of Administration: Durvalumab 1500mg plus tremelimumab 75mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination until progression.). Proton therapy 5 GyE x 5 fractions - Study Assessments and Criteria for Evaluation: Safety Assessments: according to NCI CTCAE version 4.0 Efficacy Assessments: according to RECIST version 1.1 - Statistical Methods and Data Analysis: PFS: from the date of treatment to the date of progression or death or last follow-up OS: from the date of treatment to the date of death or last follow-up - Sample Size Determination: Patients must have a histologically confirmed diagnosis of HNSCC. In this phase II study, up to approximately 27 eligible patients will be enrolled. It is anticipated that full accrual to this study will take approximately 24 months. H0: Objective response rate ≤10% H1: Objective response rate ≥35% According to Simon's two-stage optimal design (power of 90% and one-sided alpha of 0.05), this study needs total 27 evaluable patients. At the first stage, 11 patients would be enrolled. If two or more among them achieve objective response, the study will go forward the second stage. At the second stage, 16 additional patients (total 27 patients) would be enrolled. Among the total 27 evaluable patients, six or more objective responses are necessary for this drug to be evaluated further in the group of R/M HNSCC
Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+
Squamous Cell Carcinoma of Oral CavityPrimary Objective: To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes. Secondary Objectives: To determine the 2-year locoregional failure rate. To evaluate the 2-year overall survival (OS) rate. To evaluate the 2-year progression-free survival (PFS) rate. To assess the safety profiles.
Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for...
Esophageal CancerSquamous Cell2 moreThis is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.