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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Nasopharyngeal Carcinoma, Induction Chemotherapy, Radiotherapy

Intervention / Treatment
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* Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre, Non-inferiority, Randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-IC GTV<br>The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension | Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension<br>* Delineating the GTV according to the pretreatment or post-IC tumor extension<br>|
| Experimental: Post-IC GTV<br>The gross tumor volume (GTV) is delineated according to the post-IC tumor extension | Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension<br>* Delineating the GTV according to the pretreatment or post-IC tumor extension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival (RFS) | the time from randomization to documented locoregional recurrence or death from any cause | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | the time from randomization to documented death from any cause | 3 year | 
| Late toxicities | Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria | 3 months | 
| Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35) | Patient-reported QoL | 3 year | 
| Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30) | Patient-reported QoL | 3 year | 
| Distant metastasis-free survival (DMFS) | DMFS was calculated from randomization to documented distant metastasis or death. | 3 year | 
| Acute toxicities | Occur within 3 months after IMRT | 3 months |