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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nab-paclitaxel+Nedaplatin

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

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

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

Paclitaxel+Nedaplatin

induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Group Type ACTIVE_COMPARATOR

Nab-paclitaxel

Intervention Type DRUG

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

Interventions

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Nab-paclitaxel

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

Intervention Type DRUG

Other Intervention Names

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Paclitaxel for Injection (Albumin Bound)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No