Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Neoplasm Metastasis; Nasopharyngeal Carcinoma
Study type: Interventional

Summary: 
      Radiotherapy is an important treatment for initial distant metastases nasopharyngeal
      carcinoma. Total dose and fraction size are important prognostic factors for survival,
      although to our knowledge the optimal model has not been well determined to date. The purpose
      of this clinical trial is to investigate the optimal radiation dose to investigate the
      feasibility of decreasing the total dose and increasing the fraction size with the objective
      of achieving a better balance between local control and severe late complications. for
      initial distant metastases nasopharyngeal carcinoma with definitive radiotherapy.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine if hypofractionated with a smaller total dose radiation is not inferior to
      standard-dose radiation in progression-free survival for initial distant metastases
      nasopharyngeal carcinoma .

      SECONDARY OBJECTIVES:

      I. To evaluate if hypofractionated with a low total dose radiation is not inferior to
      standard-dose radiation in overall survival and locoregional failure-free survival for
      initial distant metastases nasopharyngeal carcinoma II. To evaluate if hypofractionated with
      a low total dose radiation with chemotherapy decrease treatment-related toxicities

      OUTLINE:

      Patients are randomized to one of the two treatment arms

      ARM 1: Patients receive hypofractionated with a low total dose radiation with induced
      chemotherapy and adjuvant chemotherapy.Hypofractionated dose IMRT: GTVnx 60Gy, GTVnd 60Gy,
      PTV1 50Gy and PTV2 45Gy in 25 fractions, 5 days/week.

      Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week
      chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel
      135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.

      ARM 2: Patients receive standard-dose radiation with concurrent chemotherapy. Standard-dose
      IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.

      Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week
      chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel
      135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.

      After completion of study therapy, patients are followed up every 3-4 months for 2 years,
      then every 6 months for 3 years.
    

Intervention name(s): Hypofraction radiation; Standard dose IMRT
Intervention type(s): Radiation; Radiation
Intervention description(s): Hypofractionated dose IMRT: GTVnx 60Gy, GTVnd 60Gy, PTV1 50Gy and PTV2 45Gy in 25 fractions, 5 days/week.
Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.; Standard dose IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 54.9Gy and PTV2 54Gy in 33 fractions, 5 days/week.
Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypofractionated Radiation; initial distant metastases; nasopharyngeal carcinoma