Clinical Trial: Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multicentre, Randomised Controlled Trial (CAN)

Brief Summary: This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).

Detailed Summary: In this study, NPC patients (stage III-IV A, except T3-4 N0 and T3 N1) who finished the curative radiotherapy will be randomized to the observation group and capecitabine group (650 mg/m2 bid, p.o.，d1-21，q3wks; continued until disease progression, unacceptable toxicity, or over 1 year). The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Progression-free survival [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 5 years ]
  • Distant failure-free survival [ Time Frame: 3 years ]
  • Locoregional failure-free survival [ Time Frame: 3 years ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
  • Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30 [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: October 26, 2016
Date Started: January 2017
Date Completion: December 2023
Last Updated: April 17, 2017
Last Verified: April 2017