Clinical trial NCT03668730: Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma
Official title: A Phase II Trial of Induction Chemotherapy Followed by Cisplatin With Low Dose vs. Standard Dose IMRT in Stage III Nasopharyngeal Carcinoma Patients With Pretreatment EBV DNA<4000 Copy/ml
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
IMRT
Radiation dose
induction chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.

Detailed description: To explore the 2 year PFS of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by reduced-dose radiation and cisplatin. The enrolled patients will receive 2 cycles of TPF regimen induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be delivered by 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. If radiographic SD/PD or EBV DNA\>0 after induction chemotherapy, the patients will receive a total of 70 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

The included patients will be treated with 2 cycles of TPF regimen induction chemotherapy and 60Gy IMRT combined with cisplatin concurrent chemotherapy. The TPF regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-Fu 3750mg/m2 civ120h, with a total of two cycles. Concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. The third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after IMRT finished.

Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of NPC(WHO II or III).
2. Stage III（8thAJCC/UICC staging system) and pretreatment EBVDNA\<4000opies/ml.
3. Aged 18-70 years。
4. ECOG = 0-1。
5. HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L.
6. ALT,AST\<2.5 fold of ULN；TBIL\<2.0×ULN。
7. CCR≥60ml/min or Cr\<1.5×ULN。
8. Signed informed consent

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Age \<18 or \>70years.
3. Treatment with palliative intent.
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
5. Pregnancy or lactation.
6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

Primary outcomes:
measure: PFS(progression free survival)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 2 years
measure: Locoregional relapse-free survival(LRFS)
timeFrame: 2 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 2 years
measure: Overall response rate
timeFrame: 2 years
measure: Incidence of acute toxicity
timeFrame: 2 years
measure: Incidence of late toxicity
timeFrame: 2 years
measure: Change of ADC( apparent diffusion coefficient ) value of DWI(Diffusion-Weighted MRI) of patients predictive of failure
timeFrame: 2 years
measure: Change of QoL
timeFrame: 1 years
measure: Change of EORTC quality of life questionnaire(QLQ) Head and Neck score
timeFrame: 1 years
measure: Plasma EBV DNA copy number
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hai Qiang Mai
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hai Qiang Mai, MD.PHD
role: STUDY_CHAIR
References: