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NCT Number: NCT04384627

Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy

To evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

First People's Hospital of Foshan, Foshan, Foshan, China

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About this study

This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy. The intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-IC GTV group) or post-induction chemotherapy tumor extension (the post-IC GTV group). The objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologic confirmation of nonkeratinizing nasopharyngeal carcinoma; no previous treatment for cancer; nondistant metastatic, newly diagnosed stage III to IVa disease that was staged according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); planned to receive 3 cycles of Induction Chemotherapy (regimens included docetaxel and cisplatin; docetaxel, cisplatin, and fluorouracil; and gemcitabine and cisplatin); and adequate hematologic, renal, and hepatic function.

Exclusion criteria

  • younger than 18 years or elder than 70 years; receipt of treatment with palliative intent; a history of cancer; receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx or neck; lactation or pregnancy; or severe coexisting illness; had disease progress after IC

Treatment and study plan

Delineating the GTV according to the pretreatment or post-IC tumor extension

Radiation

Delineating the GTV according to the pretreatment or post-IC tumor extension

Primary outcomes

  1. Relapse-free survival (RFS)

    Time frame: 3 year

    the time from randomization to documented locoregional recurrence or death from any cause

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 3 year

    the time from randomization to documented death from any cause

  2. Late toxicities

    Time frame: 3 months

    Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria

  3. Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)

    Time frame: 3 year

    Patient-reported QoL

  4. Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)

    Time frame: 3 year

    Patient-reported QoL

  5. Distant metastasis-free survival (DMFS)

    Time frame: 3 year

    DMFS was calculated from randomization to documented distant metastasis or death.

  6. Acute toxicities

    Time frame: 3 months

    Occur within 3 months after IMRT

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Cancer Research Institute of Zhongshan City
  • First People's Hospital of Foshan

Registry information

Official study title

Reducing Target Volumes in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy: A Phase 3, Multicentre, Non-inferiority, Randomised Controlled Trial

Acronym: NPC-GTV

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
May 12, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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