S-1 Combined With IMRT Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a prospective phase II trial which is designed to evaluate the efficacy and
      safety of IMRT combined with S-1 CCRT for locally advanced NPC. Eligibility criteria include
      histologically confirmed locally advanced NPC according to the American Joint Committee on
      Cancer (AJCC) Staging System (the eighth edition); Eastern Cooperative Oncology Group (ECOG)
      performance status of 0 or 1; at least one measurable lesion based on the Response Evaluation
      Criteria in Solid Tumors (RECIST) criteria 1.1; normal complete blood count, normal hepatic
      function and normal renal function. Prior induction chemotherapy with platinum was allowed.

      Exclusion criteria include previous radiotherapy, a history of any other type of malignancy;
      pregnancy or lactation; allergy to S-1; obvious dysfunction of liver, renal, cardiac or lung
      function; uncontrolled infection; systemic metastasis or distant metastasis; patients with
      severe gastrointestinal diseases, and patients with mental disorders affecting patient
      participation in trial judgement.

      The full-set pretreatment evaluation will be performed to every patient.All patients in this
      study will receive intensity-modulated radiation therapy (IMRT). During the IMRT course, S-1
      will be administered orally according to body surface area.The dose modifications of S-1 will
      not be permitted during concurrent chemotherapy unless progression of the disease, toxicities
      of grade 4 or patient's refusal.

      The primary endpoints of this study is adverse events (AE) rate and progression-free survival
      (PFS).
    

Detailed description: 
      This study is a prospective phase II trial which is designed to evaluate the efficacy and
      safety of IMRT combined with S-1 CCRT for locally advanced NPC. Eligibility criteria include
      histologically confirmed locally advanced NPC according to the American Joint Committee on
      Cancer (AJCC) Staging System (the eighth edition); Eastern Cooperative Oncology Group (ECOG)
      performance status of 0 or 1; at least one measurable lesion based on the Response Evaluation
      Criteria in Solid Tumors (RECIST) criteria 1.1; normal complete blood count (white blood cell
      counts ≥4×1012/L, hemoglobin level ≥100g/L and platelet counts ≥100×1012/L), normal hepatic
      function (total bilirubin level ≤1.5 mg/dl, alanine aminotransferase and aspartate
      aminotransferase levels ≤1.5 times the upper limit of normal) and normal renal function
      (creatinine ≤ 1.5 times the upper limit of normal). Prior induction chemotherapy with
      platinum was allowed.

      Exclusion criteria include previous radiotherapy, a history of any other type of malignancy;
      pregnancy or lactation; allergy to S-1; obvious dysfunction of liver, renal, cardiac or lung
      function; uncontrolled infection; systemic metastasis or distant metastasis; patients with
      severe gastrointestinal diseases, and patients with mental disorders affecting patient
      participation in trial judgement.

      The full-set pretreatment evaluation will be performed to every patient.All patients in this
      study will receive intensity-modulated radiation therapy (IMRT). During the IMRT course, S-1
      will be administered orally according to body surface area (BSA<1.25m2, 30mg; BSA:
      1.25-1.5m2, 40mg; BSA>1.5m2, 50mg).The dose modifications of S-1 will not be permitted during
      concurrent chemotherapy unless progression of the disease, toxicities of grade 4 or patient's
      refusal.

      Adverse events (AEs) will be evaluated every week during CCRT based on the evaluation
      criteria of adverse reactions of CTCAE V4.0. Tumor response is assessed at the end of CCRT
      according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
      Radiation-related acute and late toxicities are graded according to the Radiation Therapy
      Oncology Group (RTOG). Late toxicities are evaluated beyond three months from the end of
      radiotherapy.

      After the completion of CCRT, all patients will be followed up every 3 months during the
      first years, every 6 months for the following 2-5 years, and annually thereafter. Local
      recurrence is confirmed by nasopharynx MRI or histological biopsy. Regional recurrence is
      confirmed by fine needle aspiration or surgical biopsy. Distant metastases is detected by
      imaging examinations including PET-CT, bone Emission Computed Tomography (ECT), CT, MRI or
      confirmed by histological confirmation of biopsy.

      The primary endpoints of this study is adverse events (AE) rate and progression-free survival
      (PFS). PFS is calculated from the date of enrollment to the date of disease progression or
      the date of death for any cause.
    

Intervention name(s): S-1
Intervention type(s): Drug
Intervention description(s): The patients will receive IMRT combined with S-1 concurrent chemoradiotherapy. The specific treatment description is included in arm description.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal Carcinoma; IMRT; S-1