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

NCT04015661 — Phase 2, Unknown, 92 participants, Fuzhou General Hospital

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Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma

Registry	NCT04015661
Status	Unknown
Phase	Phase 2
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	92 (Estimated)
Sponsor	Fuzhou General Hospital (Other)
Conditions	Nasopharyngeal Carcinoma
Interventions	Nab-paclitaxel (Drug)
Dates	start 2019-07-09 (estimated), primary completion 2020-12-01 (estimated), completion 2022-06-01 (estimated), first posted 2019-07-11, last updated 2019-07-11
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Nab-paclitaxel+Nedaplatin	Experimental	Drug: Nab-paclitaxel	induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Paclitaxel+Nedaplatin	Active comparator	Drug: Nab-paclitaxel	induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Nab-paclitaxel (Drug), also known as Paclitaxel for Injection (Albumin Bound): induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

+Outcome measures

Primary outcomes

Objective response rate (ORR) [3 years]: To be determined by measurement of target lesions according to RECIST criteria

Secondary outcomes

Progression-Free Survival(PFS) [3 years]: From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up
Overall survival（OS） [3 years]: From the date of enrollment to the date of death is observed or to last follow-up visit

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (1)

Facility	City	Country	Status
No. 156, North Road, Xierhuan Road	Fuzhou, Fujian	China	Recruiting

+Investigators

zhichao fu, M.D, Study chair, Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy