Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuzhou General Hospital
• Treatments: Albumin-Bound Paclitaxel; Nedaplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Age, 18-75 years old.

2. Patients with newly histologically confirmed NPC.

3. WHO Type Ⅱ and Ⅲ.

4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).

5. No serious organ dysfunction of heart, lung, liver, kidney.

6. No distant metastasis.

7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.

8. Normal liver function test：Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5×ULN，creatinine clearance ≥60 ml/min.

9. Patients must be given written informed consent.

Exclusion Criteria:

1. age >75 years or <18years.

2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

3. History of previous radiotherapy and chemotherapy.

4. Known or suspected to be allergic to platinum and Nab-paclitaxel.

5. Pregnancy or lactation.

6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.

7. Peripheral sensory neuropathy> grade 1.

8. Uncontrolled heart clinical symptoms or diseases.