The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.
Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.
Taizhou Central Hospital
Taizhou, Zhejiang, China
RECRUITINGTaizhou Hospital
Taizhou, Zhejiang, China
RECRUITINGTaizhou Cancer Hospital
Taizhou, Zhejiang, China
RECRUITINGLocal-regional recurrence free survival (LRFS)
The LRFS is evaluated and calculated from the date of initiation of treatment until the day of first locoregional relapse or until the date of the last follow-up visit.
Time frame: 5 years
Overall survival (OS)
The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.
Time frame: 5 years
Progression free survival (PFS)
Progress-free survival is calculated from the date of initiation of treatment to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
Time frame: 5 years
Distant metastasis-free survival (DMFS)
The DMFS is evaluated and calculated from the date of initiation treatment until the day of first distant metastases or until the date of the last follow-up visit.
Time frame: 5 years
Incidence of treatment related acute complications
treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.
Time frame: up to 3 months
Incidence of treatment related late complications
treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.
Time frame: up to 5 years
Overall response rate
efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.
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Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China
RECRUITINGTime frame: up to 5 years