Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy, Target Volume Delineation
Conditions
Keywords
Locoregional Failure Pattern, Toxicity
Brief summary
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
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.
Interventions
RADIATIONReducing CTV
CTVs were delineated in line with tumor stage, i.e. tumor invasion.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. histologically confirmed NPC (WHO II-III) 2. stage I-IIb according to the 6th AJCC/UICC 3. no previous treatment for NPC 4. between 18 and 70 years old 5. KPS ≥ 80 scores 6. 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
1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT 2. disease progression during IMRT 3. presence of distant metastasis 4. pregnancy or lactation 5. previous malignancy or other concomitant malignant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LRRFS | 5 year | locoregional recurrence free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DMFS | 5 year | distant metastasis free survival |
| DSS | 5 year | disease specific survival |
| Locoregional failure patterns | 5 year | To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence |
| Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0) | 3 months after IMRT | National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0) |
| Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria | 5 year | Radiation Therapy Oncology Group radiation morbidity scoring criteria |
| OS | 5 year | overall survival |
Countries
China
Outcome results
None listed