Η λίστα ιστολογίων μου

Related Posts

Δημοφιλείς αναρτήσεις

Medicine by Alexandros G.Sfakianakis

Medicine by Alexandros G.Sfakianakis,Anapafseos 5 Agios Nikolao

Medicine by Alexandros G.Sfakianakis

OtoRhinoLaryngology - Head and Neck Surgery

Εμφανιζόμενη ανάρτηση

Peripheral positional vertigo and dizziness (PPVD)

The diagnostic framework of peripheral positional vertigo and dizziness (PPVD): a new concept based on the observation of alcohol-induced po...

Τετάρτη, 9 Νοεμβρίου 2016

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

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

Intervention:   Drug: Capecitabine

Sponsor:   Sun Yat-sen University



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).

ConditionInterventionPhase
Nasopharyngeal CarcinomaDrug: CapecitabinePhase 3

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multicentre, Randomised Controlled Trial (CAN)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Distant failure-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Locoregional failure-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:402
Study Start Date:December 2016
Estimated Study Completion Date:December 2023
Estimated Primary Completion Date:December 2021 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Experimental: Adjuvant capecitabine
Adjuvant chemotherapy with single-agent capecitabine
Drug: Capecitabine
Patients will receive capecitabine (650 mg/m2 bid, p.o.,d1-21,q3wks; continued until disease progression, unacceptable toxicity, or 1 year after RT).
No Intervention: Observation
Clinical follow-up and surveillance only

Detailed Description:
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 1 year after radiotherapy). 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.

Δεν υπάρχουν σχόλια:

Δημοσίευση σχολίου