Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent W... | NCT02485548

Studies
Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer

NCT02485548

Sponsor

Jiangsu Cancer Institute & Hospital

Status

Unknown status

Last Update Posted

Jun 30, 2015Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Head and Neck Squamous Cell Cancer

Interventions

Raltitrexed
5-fluorouracil
Cisplatin
IMRT

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

Jun 2015

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 2015

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Jun 26, 2015

First Submission Date that Met QC Criteria

Jun 29, 2015

First Posted Date

Jun 30, 2015Estimated

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

Jun 29, 2015

Last Update Posted Date

Jun 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Xia He, Director of Radiation Oncology, Jiangsu Cancer Institute & HospitalPrincipal Investigator

Lead Sponsor

Jiangsu Cancer Institute & HospitalOTHER

Collaborators

Name	Class
Affiliated Hospital of Jiangnan University	OTHER
Changzhou Cancer Hospital of Soochow University	OTHER
The First Affiliated Hospital with Nanjing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Detailed Description

The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Raltitrexed plus cisplatin	Experimental	Raltitrexed plus cisplatin and IMRT	Drug: Raltitrexed Drug: Cisplatin Radiation: IMRT
5-fluorouracil plus cisplatin	Active Comparator	5-fluorouracil plus cisplatin and IMRT	Drug: 5-fluorouracil Drug: Cisplatin Radiation: IMRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raltitrexed	Drug	Patients will receive IMRT and concurrent raltitrexed and cisplatin	Raltitrexed plus cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)		36 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)		36 months
Locoregional and distant control rate		36 months
Percentage of participants experiencing grade 3-5 adverse events(AEs)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed untreated head and neck squamous cell cancer patients
18-70 years
Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
Renal function: Cr ≤ 1.25×UNL
Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
ECOG ≤ 1
Woman and man of childbearing age must adopt contraception
With written consent

Exclusion Criteria:

Malignant history
Pregnant or lactating women
With other severe diseases (blood, liver ,kidney or heart diseases)
Subjects not suitable for chemo-radiotherapy
Without written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xuesong Jiang, M.D.	Contact	86138517007		13851700790@126.com

Overall Officials

Name	Affiliation	Role
Xia He, M.D.	Jiangsu Cancer Institute & Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jiangsu Cancer Hospital	Recruiting	Nanjing	Jiangsu	210009	China

Intervention Browse Module

MeSH Terms

ID	Term
C068874	raltitrexed
D005472	Fluorouracil
D002945	Cisplatin

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided