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

Phase 3

• Conditions: Nasopharyngeal Carcinoma; Neoadjuvant Chemotherapy
• Interventions: Drug: 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy; Drug: 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy

• Registration Number: NCT04061278
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08-01
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Last Update Submitted: 2020-05-10
• Last Update Posted: 2020-05-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy	3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy	3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy
4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy	4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy	Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy

Primary Outcome Measures

Name	Time	Method
5-year metastatic free survival	5 years	the duration between the date of diagnosed and date of metastasis
5-year overall survival	5 years	the duration between the date of diagnosed and date of patient death

Secondary Outcome Measures

Name	Time	Method
Safety (incidence of grade 3/4 adverse reactions)	5 years	treatment related toxic effects
5-year recurrence-free survival	5 years	the duration between the date of diagnosed and date of recurrence
5-year disease-free survival	5 years	the duration between the date of diagnosed and date of related disease

Trial Locations

Locations (12)

The first affiliated hospital, college of medicinle, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

People's Hospital of Quzhou; 🇨🇳 Quzhou, Zhejiang, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Cancer prevention and treatment center, sun yat-sen university; 🇨🇳 Guandong, Guangdong, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Xiaoshan Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Jinhua Central Hospital; 🇨🇳 Jinhua, Zhejiang, China

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Yinzhou People's Hospital; 🇨🇳 Ningbo, Zhejiang, China

Ningbo No.2 Hospital; 🇨🇳 Ningbo, Zhejiang, China

Lishui City Central Hospital; 🇨🇳 Lishui, Zhejiang, China