A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04061278
• Other study ID #: SAHZhejiangU-2019-009
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qichun Wei
• Phone: 0571-87783522
• Email: qichun_wei[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Neoadjuvant Chemotherapy

Intervention

Drug:
• 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy
4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy
• 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy
3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Cancer prevention and treatment center, sun yat-sen university	Guandong	Guangdong
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang
China	The first affiliated hospital, college of medicinle, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Zhejiang Xiaoshan Hospital	Hangzhou	Zhejiang
China	Jinhua Central Hospital	Jinhua	Zhejiang
China	Lishui City Central Hospital	Lishui	Zhejiang
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Ningbo Yinzhou People's Hospital	Ningbo	Zhejiang
China	People's Hospital of Quzhou	Quzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year overall survival	the duration between the date of diagnosed and date of patient death	5 years
Primary	5-year metastatic free survival	the duration between the date of diagnosed and date of metastasis	5 years
Secondary	5-year disease-free survival	the duration between the date of diagnosed and date of related disease	5 years
Secondary	5-year recurrence-free survival	the duration between the date of diagnosed and date of recurrence	5 years
Secondary	Safety (incidence of grade 3/4 adverse reactions)	treatment related toxic effects	5 years