Study on the Combination Regimen of Dexamethasone Ifosfam... | NCT00568607

Studies
Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma

NCT00568607

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Sep 8, 2010Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Lymphoma

Interventions

IFO, VP-16, DDP, DXM

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

Sep 2010

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

Mar 2007

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Dec 5, 2007

First Submission Date that Met QC Criteria

Dec 5, 2007

First Posted Date

Dec 6, 2007Estimated

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

Sep 7, 2010

Last Update Posted Date

Sep 8, 2010Estimated

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

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Detailed Description

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IFO, VP-16, DDP, DXM	Experimental		Drug: IFO, VP-16, DDP, DXM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IFO, VP-16, DDP, DXM	Drug	DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.

Measure	Description	Time Frame
Response rate		every two cycles

Measure	Description	Time Frame
TTP and OS		every two cycles

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range 18-75 years old
Histological confirmed NK/T cell lymphoma
ECOG performance status less than 2
Life expectancy of more than 3 months
None of major drugs in the trial (IFO,VP16,DDP) has been previously used
Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet > 100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN

Exclusion Criteria:

Pregnant or lactating women
Serious uncontrolled diseases and intercurrent infection
The evidence of CNS metastasis
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

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
Ye Guo, MD	Contact	862164175590	3252	pattrick_guo@msn.com

Overall Officials

Name	Affiliation	Role
Ye Guo, M.D.	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D054391	Lymphoma, Extranodal NK-T-Cell

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005047	Etoposide

Ancestor Terms

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided