Clinical Trial: Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma

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

Official Title: Prospective Non-inferiority Randomized Trial Comparing Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation and Traditional Clinical Target Volume in Radiotherap

Brief Summary: The purpose of this study is to compare individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation with traditional CTV in intensity modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the efficacy and safety.

Detailed Summary: Patients with non-keratinizing NPC T1-4N0-3M0 (AJCC/UICC staging system 7th edition) are randomly assigned to receive IMRT using individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation or IMRT using traditional CTV. IMRT is given as 2.13 Gray (Gy) per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor. Patients with T1N0M0 NPC receive IMRT only. For patients with stage T2-4N0-3M0 NPC, concurrent chemoradiotherapy (CCRT) is required and induction chemotherapy (IC) before CCRT is optional.Patients who participate in another randomized trial (NCT01872962) at the same time receive the protocol chemotherapy. Induction chemotherapy regimens are as follows: gemcitabine (1000 mg/m² d1,8) plus cisplatin (80mg/m² d1) or docetaxel (75mg/m² d1) plus cisplatin (75mg/m², total dose average to d1-d3) every 3 weeks for three cycles. concurrent chemotherapy include cisplatin (100mg/m² d1 or 80mg/m², total dose average to d1-d3) every 3 weeks for three cycles. Our primary endpoint is loco-regional recurrence-free survival (LRRFS) rate. Secondary end points include overall survival (OS) rate, distant metastasis-free survival (DMFS) rate, constituent ratio of local and regional recurrence pattern, toxic effects, quality of life scores and dosimetric parameters of IMRT planning. 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: Local-regional recurrence-free survival rate [ Time Frame: 3-year ]

Local-regional recurrence-free survival is calculated from the date of randomization to the date of local or regional recurrence, whichever is first.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival rate [ Time Frame: 3-year ]
    Overall survival is calculated from the date of randomization to the date of death from any cause.
  • Distant metastasis-free survival rate [ Time Frame: 3-year ]
    Distant metastasis-free survival is calculated from the date of randomization to the date of the first distant metastasis.
  • Constituent ratio of local and regional recurrence pattern [ Time Frame: 3-year ]
    Constituent ratio of local and regional recurrence pattern is defined as the proportion of in-field,marginal and out-field recurrence.
  • Number of participants with adverse events [ Time Frame: 3-year ]
    Incidence of acute and late toxicity
  • Quality of life score measured by EORTC QLQ-C30 [ Time Frame: 3-year ]
    Quality of life is measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30).
  • Quality of life score measured by EORTC H&N35 [ Time Frame: 3-year ]
    Quality of life is measured by European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Questionnaire (EORTC QLQ-H&N35).
  • Target volumes' dose coverage and doses irradiated to organs at risk [ Time Frame: 3-year ]
    For example, relative volume of planning target volume (PTV) receive 110%,95%,93% of the prescription doses;max dose or dose receive by 1% volume of brainstem; et,al.


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: December 3, 2015
Date Started: December 2015
Date Completion: December 2022
Last Updated: January 9, 2017
Last Verified: January 2017