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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2026-10-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma Induction Chemotherapy Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentre, Non-inferiority, Randomised controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pre-IC GTV

The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension

Group Type ACTIVE_COMPARATOR

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

Intervention Type RADIATION

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

Post-IC GTV

The gross tumor volume (GTV) is delineated according to the post-IC tumor extension

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

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

Interventions

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No