Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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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 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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

Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial

Brief Summary

      Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal
      carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that
      intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing
      daily dose starting at the fifth week after initiation of IMRT might improve tumor control
      and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The
      study is designed to test if late-course accelerated hyperfractionated IMRT can improve the
      outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with
      locoregionally advanced nasopharyngeal carcinoma.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Local/regional control rate, Acute and late toxicities

Secondary Outcome

 Overall survival rate

Condition

Nasopharyngeal Carcinoma

Intervention

Late-course accelerated hyperfractionated IMRT

Study Arms / Comparison Groups

 A
Description:  Late-course accelerated hyperfractionated IMRT with concomitant cisplatin 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

Radiation

Estimated Enrollment

120

Start Date

January 2008

Completion Date

December 2011

Primary Completion Date

January 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically proven non-keratinizing or undifferentiated type nasopharyngeal
             carcinoma for primary treatment with curative intent

          -  According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb

          -  Age between 18-70

          -  Karnofsky performance status ≥70

          -  WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl

          -  Without radiotherapy or chemotherapy

          -  Signed study-specific consent form prior to study entry

        Exclusion Criteria:

          -  Patients with distant metastasis

          -  Pregnant or lactating women

          -  The presence of uncontrolled life-threatening illness

          -  Patients who received radiotherapy or chemotherapy previously

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Heming Lu, MD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT00778908

Organization ID

GUIKEGONG-0816004-40

Responsible Party

Principal Investigator

Study Sponsor

Guangxi Medical University

Collaborators

 People's Hospital of Guangxi

Study Sponsor

Heming Lu, MD, Study Chair, Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region

Verification Date

August 2012