Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas...
Head and Neck NeoplasmsConcomitant radio-chemotherapy has become a standard therapy for advanced squamous cell carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis, increase in combination with radiotherapy. Mucositis, as a painful inflammation and ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one third of the patients discontinued Chemotherapy because of the side effects. Accordingly to these side effects, patients eating habits get limited. This requires an increase of pain medication, mostly an opioid derivate, which causes side effects too, which requires other symptomatic medication. This requires a change of nutrition from hard to pappy food and at further impairing, liquid food is needed. A central vein catheter has to be done for parental nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage and increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of general condition and a dose reduction or treatment stop is needed. Accordingly, the results are treatment delay and prolongation of hospital stay. Risk of the study will be the known side effects of the products: Mitomycin-C, 5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product description and the description of radiation thera-py. Another risk would be that the primary objective cannot be fulfilled. So the patients would have a lower quality of life than expected. Following benefits are expected. Benefit for patient: Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste disturbances, dietary restrictions, dysphagia Decrease of pain medication and side effects caused by pain medication Decrease of surgical intervention (gastric tube, central venous catheter) and risks caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and stomach, etc.) Improving of patients social functioning, social eating, social contact No interruptions of therapy Increase of life quality Weight stabilization Benefit for clinical practice: Increase of compliance Fulfilling of complete therapy Hospital stays as planned
Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel...
Head and Neck Squamous Cell CarcinomaPhase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.
A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma...
Cancer-related FatigueEighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was higher than the 8-11% reported in the Western populations and was related to oral submucous fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced cancer patients. This study will be investigated the effect of PG2 Injection in relieving the adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis, body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of patients with advanced pharyngeal or laryngeal SCCHN.
Role of Esophagectomy in Complete Responders to CCRT
Esophageal Squamous Cell CarcinomaTo investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy.
A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC....
Squamous Cell Carcinoma of the Head and NeckTrial Objectives: The objective is to investigate the efficacy and safety of afatinib with induction chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III or IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx. Primary Objective Phase I The primary objective of the phase I portion of the trial is to determine the maximum tolerated dose (MTD) or the recommended phase II dose of daily oral afatinib that is safe in combination with carboplatin AUC 6 and paclitaxel 175mg/m2 q 21 days as an induction regimen. Primary Objective Phase 2 The primary objective of the phase 2 portion of the trial is to estimate the objective tumor response rate and toxicity with induction therapy in patients treated on the afatinib dose determined in Phase I. Secondary Objectives The secondary objective of phase II is to estimate: 1) the overall response to entire treatment after completion of CRT, 2) progression-free survival (PFS) rate at 2 years, and 3) overall survival (OS) at 2 years.
A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck...
Squamous Cell Carcinoma of the Head and Neck (SCCHN)This study will examine the effects of an investigational drug called AT-101 in combination with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop growing? The researchers will also learn about the safety of the combination of AT-101 and Docetaxel. For instance, are there any side effects? If so, what kind of side effects does the combination cause? How severe are the side effects, and how often do they occur?
TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors...
Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-Hypopharyngeal and Laryngeal CancerTPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and toxicity of the combination regimen.
Radio-chemotherapy With or Without Panitumumab (Vectibix®) in Irresectable Squamous Cell Carcinoma...
Irresectable Squamous Cell or Adenocarcinoma of the OesophagusFor esophageal cancer that can not be removed by surgery, the choice of treatment is a combination of chemotherapy and radiotherapy. We call this combination- (or concurrent) chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The goal of treatment with chemotherapy and radiation therapy is to cure the cancer. Unfortunately only a small proportion of patients are cured with this treatment. Improvements in the outcome of treatment may be expected by using the so-called "targeted" treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that possibly the growth and spread of esophageal cancer is prevented. The main objective of this trial is to see if survival of patients with inoperable esophageal cancer improves as panitumumab is added to standard treatment with chemoradiotherapy. It will also investigate whether patients tolerate the addition of panitumumab to the standard treatment. Also, the biological characteristics of the tumor will be examined. In a proportion of patients it will be determined how the enhancement of the cancer is visible on an FDG-PET scan before the start of treatment and how this changes during the treatment. It will be also be evaluated how this treatment affects the survival.
Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent...
Head and Neck CancerCarcinoma2 moreWe propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small...
CarcinomaNon-Small-Cell Lung5 moreThe main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).