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Status unknownNCT00568607Updated Sep 8, 2010

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

A Phase 2 interventional study of IFO, VP-16, DDP, DXM in Lymphoma, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-08.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

Keywords

  • NK/T cell lymphoma
  • Response Rate
  • TTP
  • OS
  • Toxicities
03

In context

Lymphoma

5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 4,534 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    IFO, VP-16, DDP, DXM

    Drug: IFO, VP-16, DDP, DXM

Interventions

  • DrugIFO, VP-16, DDP, DXM

    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.

    Also known as: DICE

06

What researchers measure

Primary outcomes

  1. Response rate

    Time frame: every two cycles

Secondary outcomes

  1. TTP and OS

    Time frame: every two cycles

07

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Hospital
    Shanghai, Shanghai Municipality 200032, China
    • Biyun Wang, MD · Contact · wangbiyun@msn.com · 8613701748410
    • Biyun Wang, M.D. · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2007, a primary completion of Dec 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2007
First posted
Dec 6, 2007
Start
Mar 2007
Primary completionEst.
Dec 2010
CompletionEst.
Dec 2010
Last update
Sep 8, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00568607
Lead sponsor
Fudan University
First posted
Dec 6, 2007
Start date
Mar 2007
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Sep 8, 2010

Study contacts

Ye Guo, MD
Contact
pattrick_guo@msn.com
862164175590 ext. 3252
Ye Guo, M.D.
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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