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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04015661

20190515

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 2 patient groups

Nab-paclitaxel+Nedaplatin

Experimental group

Description:

induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Treatment:

Drug: Nab-paclitaxel

Paclitaxel+Nedaplatin

Active Comparator group

Description:

induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Treatment:

Drug: Nab-paclitaxel