Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

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Brief Title

Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

Official Title

Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Brief Summary

      The purpose of this study is to compare the efficacy and safety of sequential
      chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant
      chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with
      locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of
      sequential chemoradiotherapy in NPC patients.

Detailed Description

      Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to
      receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated
      radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent
      chemoradiotherapy. Intensity-modulated radiotherapy (IMRT) is given as 2.2 Gy per fraction
      with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the
      primary tumor. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8)
      and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is
      given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is
      failure-free survival(FFS) and grade III mucositis during radiation. Secondary end points
      include overall survival (OS), locoregional failure-free survival (LR-FFS), distant
      failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in
      the intention-to-treat population, and the safety population include only patients who
      receive their randomly assigned treatment.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Failure-free survival

Secondary Outcome

 Overall survival

Condition

Nasopharyngeal Carcinoma

Intervention

gemcitabine and cisplatin (Induction and adjuvant chemotherapy)

Study Arms / Comparison Groups

 Induction chemotherapy+IMRT+adjuvant chemotherapy
Description:  Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 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

420

Start Date

December 1, 2017

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with newly histologically confirmed non-keratinizing (according to WHO
             histologically type)

          -  Tumor staged as III-IVA (according to the 8th AJCC edition).

          -  Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.

          -  Age between 18 and 60 years old.

          -  Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count
             ≥100000/μL.

          -  Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase
             (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤
             2.5×ULN, and bilirubin ≤ 1.5ULN.

          -  Adequate renal function: creatinine clearance ≥60 ml/min.

          -  Patients must be informed of the investigational nature of this study and give written
             informed consent.

        Exclusion Criteria:

          -  Evidence of distant metastasis

          -  Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or
             nodes.

          -  Other previous or concomitant cancer.

          -  Pregnancy or lactation.

          -  Presence of an uncontrolled concomitant illness including, but not limited to, ongoing
             or active infection, immune deficiency, symptomatic congestive heart failure, unstable
             angina pectoris, cardiac arrhythmia or emotional disturbance.

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, +86 18017312302, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03366415

Organization ID

GP2017-02

Responsible Party

Sponsor-Investigator

Study Sponsor

Chaosu Hu

Collaborators

 Zhejiang Cancer Hospital

Study Sponsor

, ,

Verification Date

January 2018