De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

Overview

The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.

Full Title of Study: “De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Radiation: Toxicities reduced treatment
    • Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.
  • Radiation: Conventional treatment
    • Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.

Arms, Groups and Cohorts

  • Experimental: Toxicities reduced treatment
    • Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
  • Active Comparator: Conventional treatment
    • Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).

Clinical Trial Outcome Measures

Primary Measures

  • DFS
    • Time Frame: 3 year
    • Disease Free Survival

Secondary Measures

  • OS
    • Time Frame: 3 year
    • Overall Survival

Participating in This Clinical Trial

Inclusion Criteria

  • Histological diagnosis of nasopharyngeal carcinoma
  • Stage III or IVA according to UICC/AJCC 8th staging system
  • Age ≥18
  • No prior anti-tumor treatment
  • Karnofsky Performance Score (KPS)≥70
  • Adequate blood supply
  • Informed consent obtained

Exclusion Criteria

  • Can not take contrast-MRI imaging
  • Pregnant
  • Combined with other malignant tumor (except basal cell carcinoma of skin)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chaosu Hu
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Chaosu Hu, Principal Investigator – Fudan University
  • Overall Official(s)
    • Chaosu Hu, MD, Principal Investigator, Fudan University Shanghai Cancer Centre
  • Overall Contact(s)
    • Youqi Yang, MD, +8613916162859, yangyq@sina.com

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