Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients

Study Overview
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Brief Summary
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To analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT).

Detailed Description
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The investigators designed a prospective phase II study for early-stage NPC patients, and proposed a reasonable delineation method of reducing CTV according to the clinical characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and prophylactic dose to CTV while protecting as much normal tissues as possible, in order to ensure a long-term survival with good quality of life.

Official Title
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Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal

Conditions
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Target Volume Delineation, Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy

Intervention / Treatment
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* Radiation: Reducing CTV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed NPC (WHO II-III) stage I-IIb according to the 6th AJCC/UICC no previous treatment for NPC between 18 and 70 years old KPS ≥ 80 scores adequate organ function (white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥ 1.5×109/L; hemoglobin ≥ 100g/L; platelet count ≥ 100×109/L; total bilirubin, aspartate aminotransferase and alanine aminotransferase ≤ 1.5X upper limit normal; and creatinine clearance rate ≥ 30 mL/min) Exclusion Criteria: fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT disease progression during IMRT presence of distant metastasis pregnancy or lactation previous malignancy or other concomitant malignant disease

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
Intervention Model: Single Group Assignment
Interventional Model Description: The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reducing CTV<br>The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively. | Radiation: Reducing CTV<br>* CTVs were delineated in line with tumor stage, i.e. tumor invasion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LRRFS | locoregional recurrence free survival | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional failure patterns | To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence | 5 year | 
| DMFS | distant metastasis free survival | 5 year | 
| DSS | disease specific survival | 5 year | 
| OS | overall survival | 5 year | 
| Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0) | National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0) | 3 months after IMRT | 
| Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria | Radiation Therapy Oncology Group radiation morbidity scoring criteria | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locoregional Failure Pattern, Toxicity