Brief Title
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC
Official Title
Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (ORR)
Secondary Outcome
Progression-Free Survival(PFS)
Condition
Nasopharyngeal Carcinoma
Intervention
Nab-paclitaxel
Study Arms / Comparison Groups
Nab-paclitaxel+Nedaplatin
Description: induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
92
Start Date
July 9, 2019
Completion Date
June 1, 2022
Primary Completion Date
December 1, 2020
Eligibility 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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
zhichao fu, M.D, 228 59125, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04015661
Organization ID
20190515
Responsible Party
Sponsor
Study Sponsor
Fuzhou General Hospital
Study Sponsor
zhichao fu, M.D, Study Chair, Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy
Verification Date
July 2019