Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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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 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Brief Title

Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Brief Summary

      The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant
      chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC,
      in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC)
      patients.

Detailed Description

      Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly
      assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational
      arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical
      radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the
      investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1
      to 5) every four weeks for three cycles after completion of radiotherapy. Patients are
      stratified according to the treatment centers. The primary end point was failure-free
      survival (FFS). Secondary end points included overall survival (OS), distant failure-free
      survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates
      after treatments, toxic effects and treatment compliance. All efficacy analyses were
      conducted in the intention-to-treat population; the safety population included only patients
      who received their randomly assigned treatment.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Failure-free survival

Secondary Outcome

 Overall survival, distant failure-free survival and locoregional failure-free survival

Condition

Nasopharyngeal Carcinoma

Intervention

Cisplatin,fluorouracil

Study Arms / Comparison Groups

 Concurrent and adjuvant
Description:  Concurrent chemoradiotherapy plus adjuvant chemotherapy

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

506

Start Date

June 2006

Completion Date

March 2015

Primary Completion Date

March 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to
             World Health Organization (WHO) histologically type)

          2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer
             staging system)

          3. No evidence of distant metastasis (M0)

          4. Performance status: KPS ≥70

          5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase
             ≤2.5×upper limit of normal)

          6. Renal: creatinine clearance ≥60ml/min

          7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count
             ≥100000/μL

          8. Written informed consent

        Exclusion Criteria:

          1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

          2. Age ≥70 or <18

          3. With a history of renal disease

          4. Prior malignancy

          5. Previous chemotherapy or radiotherapy

          6. Patient is pregnant or lactating

          7. Unstable cardiac disease requiring treatment.

          8. Emotion disturbance

Gender

All

Ages

18 Years - 69 Years

Accepts Healthy Volunteers

No

Contacts

Jun Ma, M.D., ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT00677118

Organization ID

YP2008004

Study Sponsor

Sun Yat-sen University

Collaborators

 Fudan University

Study Sponsor

Jun Ma, M.D., Study Chair, Sun Yat-sen University

Verification Date

March 2010