New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

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A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL) Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC) Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma Weekly Plasma EBV DNA for Non-metastatic Nasopharyngeal Carcinoma Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma MK-2206 in Recurrent Nasopharyngeal Carcinoma Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma Prospective Comparisons of Clinical Trial and Real-world Outcomes in Nasopharyngeal Carcinoma Serial Plasma EBV DNA for Nasopharyngeal Carcinoma Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma A Trial On 4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation In N2-3 Nasopharyngeal Carcinoma Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients Endostar for Locally Recurrent Nasopharyngeal Carcinoma Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo Metastatic Nasopharyngeal Carcinoma The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA) Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Administration of Epstein Barr Virus – Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC) Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy. Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC) Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma Clinical Study of EBV-LMP1 Targeted DNAzyme to Treat Nasopharyngeal Carcinoma TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC) Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma SOX as Salvage Treatment in Nasopharyngeal Carcinoma Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer Demethylated Drug in the Treatment of Nasopharyngeal Carcinoma A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma. Phase Ⅲ Trial of Adjuvant Chemotherapy in Patients With N2-3 Nasopharyngeal Carcinoma TPF+CCRT vs.CCRT+PF in High Risk Nasopharyngeal Carcinoma Nimotuzumab for Recurrent Nasopharyngeal Carcinoma Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer Swallowing Pattern of Patients With Nasopharyngeal Cancer Before and After Radiation Therapy: Longitudinal Study and Correction With Saliva Amount Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Screening for Nasopharyngeal Carcinoma in High Risk Populations EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer PET/MR in Locally Advanced Nasopharyngeal Carcinoma Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma Dendritic Cell Therapy With CD137L-DC-EBV-VAX in Locally Advanced Stage IV or Locally Recurrent/Metastatic Nasopharyngeal Carcinoma Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer Nasopharyngeal Carcinoma Screening in Zhongshan City Nasopharyngeal Carcinoma Post IMRT To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer Parotid-sparing IMRT for Nasopharyngeal Cancer Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer. 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Brief Title

New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Official Title

Prospective Evaluation of Plasma EBV DNA Half-life and PET-CT Scanning as a New Tool in Assessing Early Response to Chemotherapy in Patients With Advanced Nasopharyngeal Carcinoma

Brief Summary

      The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow
      earlier and more detection of drug response in advanced NPC than RECIST method, in patients
      with previously untreated advanced NPC who will receive platinum-based chemotherapy. This
      study will also determine if this new method can predict survival in these patients. This
      study may have far-reaching impact on drug development in NPC as it may offer a more optimal
      way of evaluating drug efficacy in clinical trials and also in clinical management.

Study Type

Observational

Primary Outcome

To determine if measuring tumor metabolic response during chemotherapy can predict survival

Secondary Outcome

 New method of assessing drug response (measuring tumor metabolic response via FDG-PET & plasma EBV DNA (half-life) after 1 course of chemotherapy) can better predict survival, than the conventional method

Condition

Advanced Nasopharyngeal Carcinoma

Intervention

Chemotherapy

Study Arms / Comparison Groups

 advanced nasopharyngeal carcinoma
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

70

Start Date

July 2011

Completion Date

March 3, 2017

Primary Completion Date

March 3, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  undergo chemotherapy for any one of the following settings:

               1. Setting 1: Neoadjuvant chemotherapy prior to cheom-RT

               2. Setting 2: Palliative chemotherapy in Chemonaive patients

               3. Setting 3: Palliative chemotherapy in previously treated patients (i.e. 2nd line
                  or 3rd line chemo)

          -  Age >= 18 years

          -  (ECOG) performance status of 0-2

          -  have detectable levels of pEBV DNA at baseline

          -  have measurable tumor sites by RECIST criteria

          -  have adequate bone marrow, renal and hepatic functions

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Brigette Ma, MD, FRCP, ,

Location Countries

Hong Kong

Location Countries

Hong Kong

Administrative Informations

NCT ID

NCT01365208

Organization ID

NPC023

Responsible Party

Principal Investigator

Study Sponsor

Chinese University of Hong Kong

Study Sponsor

Brigette Ma, MD, FRCP, Principal Investigator, Chinese University of Hong Kong

Verification Date

March 2017