A Multicenter Trial Comparing Multi-course Chemotherapy i... | NCT00705627

Studies
A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT00705627

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

May 28, 2014Estimated

Enrollment

400Estimated

Phase

Phase 3

Conditions

Nasopharyngeal Carcinoma

Interventions

neoadjuvant chemotherapy plus concurrent chemoradiotherapy

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

May 2014

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

Jun 2008

Primary Completion Date

Feb 2015Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Jun 24, 2008

First Submission Date that Met QC Criteria

Jun 25, 2008

First Posted Date

Jun 26, 2008Estimated

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

May 26, 2014

Last Update Posted Date

May 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Ming-huang, the director of GCP, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Name	Class
Guangdong Provincial People's Hospital	OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University	OTHER
Affiliated Cancer Hospital of Shantou University Medical College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.

In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Experimental	Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.	Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neoadjuvant chemotherapy plus concurrent chemoradiotherapy	Drug	Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
distant metastasis free survival,disease free survival		5-Yr

Secondary Outcomes

Measure	Description	Time Frame
overall survival		5-Yr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
Original clinical stage must be T4 or N2-3 （UICC 2002）
Male and no pregnant female
Age between 18-60
WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
With normal liver function test (ALT、AST≤2.5×ULN)
With normal renal function test (Creatinine ≤ 1.5×ULN)
Performance status scale ECOG grade 0，1
Without radiotherapy or chemotherapy
Patients must give signed informed consent

Exclusion Criteria:

Patients have evidence of relapse or distant metastasis
The presence of uncontrolled life-threatening illness
Receiving other ways of anti-cancer therapy
Receiving radiotherapy or chemotherapy
Investigator consider the patients can't finish the whole study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sumei Cao, Ph. D.	Contact	86-20-8734-5685		caosumei@mail/sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Minghuang Hong, MD	Sun Yet sen Cancer Center, China	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510060	China

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
D020360	Neoadjuvant Therapy
D059248	Chemoradiotherapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D011878	Radiotherapy

Browse Leaves

Not provided

Browse Branches

Not provided