Nasopharyngeal Carcinoma
Conditions
Keywords
Neoadjuvant Chemotherapy, Intensity-modulated Radiation Therapy, Target Volume Delineation, Locoregional Failure Pattern, Nasopharyngeal Carcinoma
Brief summary
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.
Interventions
RADIATIONTarget Volume Delineation after NACT
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. histologically confirmed NPC; 2. no evidence of distant metastasis; 3. no previous treatment for NPC; 4. stages III-IVb disease according to the staging system of the 6th AJCC/UICC; 5. adequate liver, renal and bone marrow function; 6. Karnofsky Performance Status (KPS) ≥80 scores.
Exclusion criteria
1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT; 2. disease progression during NACT; 3. presence of distant metastasis; 4. pregnancy or lactation; 5. previous malignancy or other concomitant malignant disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year loco-regional recurrence free survival (LRRFS) | Five years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 local recurrence free survival (LRFS) | Five years | — |
| Locoregional failure patterns | Five years | 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. |
| Late toxicities | Five years | The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria. |
| 5-year overall survival (OS) | Five years | — |
Countries
China
Outcome results
None listed