A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
NCT04215510 — Recurrent Nasopharyngeal Carcinoma
Status: Not yet recruiting
http://inclinicaltrials.com/recurrent-nasopharyngeal-carcinoma/NCT04215510/
Phase 3, Double-Blind, Randomized Study to Compare the Efficacy and Safety of Tislelizumab Combined With Chemotherapy Versus Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
This is a Phase 3, Multicenter, Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Tislelizumab (BGB-A317) Combined With Gemcitabine Plus Cisplatin Versus Placebo Combined With Gemcitabine Plus Cisplatin as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer.
NCT03924986 — Recurrent or Metastatic Nasopharyngeal Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/recurrent-or-metastatic-nasopharyngeal-cancer/NCT03924986/
NEO-SPACE Trial: Neoadjuvant Pembrolizumab-Gemcitabine-Cisplatin Followed by Concurrent Pembrolizumab-Chemoradiation and Maintenance Pembrolizumab for Stage IVA Nasopharyngeal Cancer
This is an open label, single arm, non-randomized, multi-site, phase 2 clinical trial of neoadjuvant pembrolizumab in combination with gemcitabine-cisplatin for 2 cycles,followed by concurrent pembrolizumab-cisplain-radiation, and then maintainence pembrolizumab monotherpy given every 3 weeks for a total treatment duration of 12 months, in previously untreated stage IVA ( UICC 8 th Edition ) nasopharyngeal cancer(NPC).
NCT03734809 — NPC
Status: Active, not recruiting
http://inclinicaltrials.com/npc/NCT03734809/
Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer
Hypothesis: To estimate the proportion of locally advanced, recurrent or metastatic nasopharyngeal cancer patients which show high somatostatin receptor density (SUVmax >10) on Ga-68 DOTATATE imaging. Galium-68 DOTATATE: PET imaging will be performed with a PET/CT scanner. Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection. The standardized uptake value (SUV) will be used in the interpretation of the Ga-68 DOTATATE scans. The values gathered will be used as an estimate of the somatostatin receptor density. A patient will be considered to have an overall high somatostatin receptor density if the average SUVmax of all the representative lesions is more than 10.
NCT03670342 — Nasopharyngeal Carcinoma
Status: Completed
http://inclinicaltrials.com/nasopharyngeal-carcinoma/NCT03670342/
Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI
The overarching goal of this study is to develop PET/MR techniques for accurate assessment of treatment response during and immediately after chemoradiation therapy. The central hypothesis is that the GMR measured using a simultaneous PET/MR scanner can more accurately detect residual tumor than conventional SUV measures from PET alone. It is important to note that SUV depends on both tumor metabolic rate and tracer delivery, which makes the interpretation of SUV challenging. For instance, inflammatory tissue can have high SUV due to increased vascularity and vascular permeability and cannot be easily differentiated from tumor based on the SUV. Investigators hypothesize that inflammatory tissue will have lower GMR than residual tumor that contain highly proliferating cells with increased expression of glucose transporters (GLUT). Measuring GMR accurately will improve the specificity of PET while maintaining the high sensitivity of PET for detection of residual tumor. In order to test our hypothesis, investigators propose to conduct dynamic PET and MRI scans with NPC patients who are undergoing a conventional two-stage chemoradiation therapy at our institution; the first stage for 7-week chemoradiation therapy followed by the second stage for 3-month chemotherapy. A combination of PET/CT and nasopharynx MRI is currently obtained before the initiation of treatment and 3 months after completion of treatment to assess treatment response. This study proposes to introduce PET/MR scans at the time of these exams (scan #1 for pre-treatment & scan #4 for 3 months after completion) and to add two additional PET/MR scans in between them; one immediately after the first stage of treatment (scan #2) and another one immediately after the second stage (scan #3). A primary clinical endpoint of this study is the treatment response assessed at 3 months after completion of treatment. A secondary endpoint is 6 month follow-up exam. Complete responder will be determined based on clinical and imaging assessment of residual tumor size at each endpoint. It is hoped that preliminary data obtained from this study will be useful in planning larger studies to formally investigate the utility of GMR for detection of residual tumor and prediction of treatment response.
NCT03656250 — Nasopharyngeal Cancer
Status: Completed
http://inclinicaltrials.com/nasopharyngeal-cancer/NCT03656250/
Efficacy and Safety of Lappaconitine Adhesive Patch for the Treatment of Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer ： A Randomized, Prospective Single-center Controlled Study
The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.
NCT03518489 — Radiation Induced Oral Mucositis
Status: Not yet recruiting
http://inclinicaltrials.com/radiation-induced-oral-mucositis/NCT03518489/
The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of nasopharyngeal cancer.
NCT03007836 — Metastatic Nasopharyngeal Cancer
Status: Completed
http://inclinicaltrials.com/metastatic-nasopharyngeal-cancer/NCT03007836/
Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma. 2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability. 3）observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
NCT02937519 — Esophageal Neoplasms
Status: Recruiting
http://inclinicaltrials.com/esophageal-neoplasms/NCT02937519/
An Open-label, Single-arm, Multi-institutional Phase II Trial of Avelumab for Recurrent, Metastatic Nasopharyngeal Carcinoma
The purpose of this study is to determine whether avelumab, an investigational antibody against programmed death-ligand (PD-L1), has an effect on recurrent nasopharyngeal cancer. Avelumab is designed to block the interaction between programmed cell death protein 1 (PD-1), a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer.
NCT02875613 — Nasopharyngeal Cancer
Status: Terminated
http://inclinicaltrials.com/nasopharyngeal-cancer/NCT02875613/
A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.
NCT02608073 — Nasopharyngeal Cancer
Status: Completed
http://inclinicaltrials.com/nasopharyngeal-cancer/NCT02608073/