Clinical trial NCT04061278: A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients
Official title: A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Neoadjuvant Chemotherapy
Keywords: Nasopharyngeal Carcinoma
Neoadjuvant Chemotherapy
Concurrent Chemoradiotherapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.


Eligibility criteria: Inclusion Criteria:

1. Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
2. According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
3. Patients who have not received disease-related anti-tumor system therapy;
4. Age 18\~70 years;
5. Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
6. Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
7. Cartesian score ≥70; or ECOG PS 0 or 1
8. Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
9. Sign the informed consent.

Exclusion Criteria:

1. Patients with distant metastases were identified at the time of diagnosis;
2. Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
3. Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
4. Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
5. A woman who is pregnant or lactating;
6. Known active HIV or HBV, HCV infection;
7. Known to be allergic to drugs that may be used;
8. The researchers did not consider participants to be eligible for this study.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
measure: 5-year metastatic free survival
timeFrame: 5 years
Secondary outcomes:
measure: 5-year disease-free survival
timeFrame: 5 years
measure: 5-year recurrence-free survival
timeFrame: 5 years
measure: Safety (incidence of grade 3/4 adverse reactions)
timeFrame: 5 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guandong
country: China
facility: Cancer prevention and treatment center, sun yat-sen university
state: Guangdong
city: Hangzhou
country: China
facility: The first affiliated hospital, college of medicinle, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Xiaoshan Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui City Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Yinzhou People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Quzhou
country: China
facility: People's Hospital of Quzhou
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Qichun Wei
role: STUDY_CHAIR
References: