search
Back to results

Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

Primary Purpose

Extranodal NK/T-cell Lymphoma, Nasal Type

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy followed by chemotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type focused on measuring NK/T-cell lymphoma, Radiotherapy, Adjuvant chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range 14-70 years old
  • Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
  • ECOG performance status 0-1
  • Life expectancy of more than 3 months
  • Without prior history of pancreatitis
  • Adequate bone marrow and organ functions

Exclusion Criteria:

  • Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
  • Pregnant or lactating women
  • With contraindication of steroid including uncontrolled diabetes
  • Serious uncontrolled diseases and intercurrent infection
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy followed by chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

3-year Progression-free survival

Secondary Outcome Measures

Overall response rate
3-year overall survival
Safety

Full Information

First Posted
August 13, 2012
Last Updated
March 2, 2013
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT01667302
Brief Title
Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
Official Title
A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords
NK/T-cell lymphoma, Radiotherapy, Adjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy followed by chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Radiotherapy followed by chemotherapy
Other Intervention Name(s)
DXM, IFO, VP-16, DDP, PEG-ASP
Intervention Description
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
Primary Outcome Measure Information:
Title
3-year Progression-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
3 years
Title
3-year overall survival
Time Frame
3 years
Title
Safety
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 14-70 years old Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract ECOG performance status 0-1 Life expectancy of more than 3 months Without prior history of pancreatitis Adequate bone marrow and organ functions Exclusion Criteria: Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level) Pregnant or lactating women With contraindication of steroid including uncontrolled diabetes Serious uncontrolled diseases and intercurrent infection History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Guo, MD
Phone
862164175590
Email
pattrick_guo@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
SHanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Phone
862164175590
Email
pattrick_guo@msn.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32519518
Citation
Liu Y, Xue K, Xia Z, Jin J, Wang J, Sun H, Lv F, Liu X, Cao J, Hong X, Guo Y, Ma X, Zhang Q. Radiotherapy followed by DICEP regimen in treatment of newly diagnosed, stage IE/IIE, extranodal NK/T-cell lymphoma patients. Cancer Med. 2020 Aug;9(15):5400-5405. doi: 10.1002/cam4.3207. Epub 2020 Jun 9.
Results Reference
derived

Learn more about this trial

Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

We'll reach out to this number within 24 hrs