Clinical trial NCT03839602: Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients
Official title: Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Target Volume Delineation
Early-stage Nasopharyngeal Carcinoma
Intensity Modulated Radiation Therapy
Keywords: Locoregional Failure Pattern
Toxicity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: LRRFS
timeFrame: 5 year
Secondary outcomes:
measure: Locoregional failure patterns
timeFrame: 5 year
measure: DMFS
timeFrame: 5 year
measure: DSS
timeFrame: 5 year
measure: OS
timeFrame: 5 year
measure: Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)
timeFrame: 3 months after IMRT
measure: Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
timeFrame: 5 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Miao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6.