NCT04015661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

July 9, 2019

Last Update Submit

July 9, 2019

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    To be determined by measurement of target lesions according to RECIST criteria

    3 years

Secondary Outcomes (2)

  • Progression-Free Survival(PFS)

    3 years

  • Overall survival（OS）

    3 years

Study Arms (2)

Nab-paclitaxel+Nedaplatin

EXPERIMENTAL

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

Drug: Nab-paclitaxel

Paclitaxel+Nedaplatin

ACTIVE COMPARATOR

induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Drug: Nab-paclitaxel

Interventions

Nab-paclitaxelDRUG

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

Also known as: Paclitaxel for Injection (Albumin Bound)
Nab-paclitaxel+NedaplatinPaclitaxel+Nedaplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, 18-75 years old.
  • Patients with newly histologically confirmed NPC.
  • WHO Type Ⅱ and Ⅲ.
  • Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
  • No serious organ dysfunction of heart, lung, liver, kidney.
  • No distant metastasis.
  • Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
  • 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.
  • Patients must be given written informed consent.

You may not qualify if:

  • age \>75 years or \<18years.
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • History of previous radiotherapy and chemotherapy.
  • Known or suspected to be allergic to platinum and Nab-paclitaxel.
  • Pregnancy or lactation.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
  • Peripheral sensory neuropathy\> grade 1.
  • Uncontrolled heart clinical symptoms or diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 156, North Road, Xierhuan Road

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

130-nm albumin-bound paclitaxelPaclitaxelInjections

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • zhichao fu, M.D

    Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy

    STUDY CHAIR

Central Study Contacts

wenmin ying, bachelor

CONTACT

228 5912518352770@qq.com

xiaoyan li

CONTACT

228 59125

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 11, 2019

Study Start

July 9, 2019

Primary Completion

December 1, 2020

Study Completion

June 1, 2022

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)