SOX as Salvage Treatment in 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 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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 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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 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Brief Title

SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Official Title

Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Brief Summary

      The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus
      oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal
      carcinoma.

Detailed Description

      The treatment option in patients with platinum-resistant relapsed or metastatic
      nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin
      were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be
      tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in
      salvage setting of nasopharyngeal carcinoma.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Median progression-free survival

Secondary Outcome

 Overall response rate

Condition

Nasopharyngeal Carcinoma

Intervention

S-1 plus oxaliplatin

Study Arms / Comparison Groups

 S-1 plus oxaliplatin
Description:  S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles

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

16

Start Date

July 2011

Completion Date

December 2015

Primary Completion Date

December 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Age range: 18-75 years old

          -  Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma

          -  Prior exposure of at least one line of platinum-containing regimen

          -  ECOG performance status 0-1

          -  Life expectancy of more than 3 months

          -  Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L

          -  Liver function: total bilirubin, ALT and AST <1.5×UNL

          -  Renal function: Cr<1.5×UNL, CCR≧50ml/min

          -  Without > 1 grade of neuropathy

        Exclusion Criteria:

          -  With curable treatment option

          -  With CNS involvement

          -  Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used
             with radiotherapy

          -  Treated with > 2 lines of palliative chemotherapy

          -  With prior exposure of S-1 or oxaliplatin

          -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma
             in-situ of uterine cervix

          -  Significant active infection

          -  Pregnant or lactating women

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ye Guo, MD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01403259

Organization ID

HNTG 11-02

Responsible Party

Principal Investigator

Study Sponsor

Fudan University

Study Sponsor

Ye Guo, MD, Principal Investigator, Fudan University

Verification Date

August 2014