Suspended

A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma

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What is being tested

Radiotherapy followed by chemotherapy

Drug
Who is being recruted

Lymphoma+3

+ Lymphoma, Non-Hodgkin

+ Neoplasms

From 18 to 70 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorFudan University
Study ContactYe Guo, MDMore contacts
Last updated: March 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

NCT01667302
Principal SponsorFudan University
Study ContactYe Guo, MDMore contacts
Last updated: March 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphomaLymphoma, Non-HodgkinNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphoma, Extranodal NK-T-Cell

Criteria

6 inclusion criteria required to participate
Adequate bone marrow and organ functions
Age range 14-70 years old
ECOG performance status 0-1
Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
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5 exclusion criteria prevent from participating
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
Pregnant or lactating women
Serious uncontrolled diseases and intercurrent infection
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fudan University Cancer Hospital

Shanghai, ChinaOpen Fudan University Cancer Hospital in Google Maps
SuspendedOne Study Center