Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT

Study Overview
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Brief Summary
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The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be delineated according to the post-NACT tumor position and receive radical radiation dose, while the tumor disappear after NACT could be encompassed in the first clinical target volume (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to achieve the ultimate goal that maximize the chance of cure while minimize the injury of surrounding normal tissues, maintaining organ function and life quality. Therefore, this stage II clinical trial was designed to study the prognosis and locoregional failure patterns of this target volume delineation method in LA-NPC treated with NACT plus CCRT.

Official Title
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Study on Delineation of the Target Volumes and Determination of the Irradiation Doses in Untreated Nasopharyngeal Carcinoma (NPC) Treated With Intensity Modulated Radiation Therapy (IMRT)

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Radiation: Target Volume Delineation after NACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed NPC; no evidence of distant metastasis; no previous treatment for NPC; stages III-IVb disease according to the staging system of the 6th AJCC/UICC; adequate liver, renal and bone marrow function; Karnofsky Performance Status (KPS) ≥80 scores. Exclusion Criteria: fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT; disease progression during NACT; presence of distant metastasis; pregnancy or lactation; previous malignancy or other concomitant malignant disease.

Ages Eligible for Study
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Minimum Age: 14 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Target volume delineation after NACT<br> | Radiation: Target Volume Delineation after NACT<br>* The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT. The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT. The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area. The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year loco-regional recurrence free survival (LRRFS) |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year local recurrence free survival (LRFS) |  | Five years | 
| 5-year regional recurrence free survival (RRFS) |  | Five years | 
| 5-year distant metastasis free survival (DMFS) |  | Five years | 
| 5-year disease specific survival (DSS) |  | Five years | 
| 5-year overall survival (OS) |  | Five years | 
| Locoregional failure patterns | The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: in field if 95% of Vrecur was within the 95% isodose; marginal if 20% to 95% of Vrecur was within the 95% isodose, or outside if less than 20% of Vrecur was inside the 95% isodose. | Five years | 
| Late toxicities | The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant Chemotherapy, Intensity-modulated Radiation Therapy, Target Volume Delineation, Locoregional Failure Pattern, Nasopharyngeal Carcinoma