Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma

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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. 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Brief Title

Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma

Official Title

Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity

Brief Summary

      This is a randomized parallel control trial to evaluate whether radical loco-regional
      Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal
      carcinoma.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival

Secondary Outcome

 Progress-free survival

Condition

Nasopharyngeal Carcinoma

Intervention

Loco-regional Radiotherapy

Study Arms / Comparison Groups

 Radiotherapy
Description:  Systemic Chemotherapy Combined with Loco-regional Radiotherapy

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

Radiation

Estimated Enrollment

126

Start Date

October 2013

Completion Date

December 2022

Primary Completion Date

August 2019

Eligibility Criteria

        Inclusion Criteria:

          -  The patients with initial untreated metastatic nasopharyngeal carcinoma

          -  Histologic diagnosis of nasopharyngeal carcinoma

          -  T1-4N0-3M1,IVC(according to the 7th AJCC edition)

          -  Aged between 18 and 65 years

          -  KPS≥70

          -  The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin
             and 5-Fu

          -  Voluntary to participate and sign informed consent document

        Exclusion Criteria:

          -  The patients suffered from serious neurologic disease

          -  Clinically significant cardiac, heart function less than or equal to 3 level

          -  Clinically significant respiratory disease,lung function less than or equal to 3 level

          -  Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L

          -  Abnormal liver function: total bilirubin or ALT or AST>2×ULN

          -  Abnormal renal function:serum creatinine>1.5×ULN

          -  Pregnant or lactating women

          -  The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin
             and 5-Fu

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ming y Chen, MD,Phd, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02111460

Organization ID

SYSUCC5010

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Collaborators

 First Affiliated Hospital, Sun Yat-Sen University

Study Sponsor

Ming y Chen, MD,Phd, Principal Investigator, Sun Yat-sen University

Verification Date

May 2020