Induction Chemotherapy Followed by Concurrent Chemoradiot... | NCT04015661

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

NCT04015661

Sponsor

Fuzhou General Hospital

Status

Unknown status

Last Update Posted

Jul 11, 2019Actual

Enrollment

92Estimated

Phase

Phase 2

Conditions

Nasopharyngeal Carcinoma

Interventions

Nab-paclitaxel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2019Estimated

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Jul 9, 2019

First Submission Date that Met QC Criteria

Jul 9, 2019

First Posted Date

Jul 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2019

Last Update Posted Date

Jul 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nab-paclitaxel	Drug	induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy	Nab-paclitaxel+Nedaplatin Paclitaxel+Nedaplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	To be determined by measurement of target lesions according to RECIST criteria	3 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
wenmin ying, bachelor	Contact	228 59125		18352770@qq.com
xiaoyan li	Contact	228 59125

Overall Officials

Name	Affiliation	Role
zhichao fu, M.D	Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy	Study Chair

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520255	130-nm albumin-bound paclitaxel
D017239	Paclitaxel
D007267	Injections

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided