Back to resultsRadiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
Primary Purpose
Extranodal NK/T-cell Lymphoma, Nasal Type
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy alone
Concurrent chemoradiation
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type focused on measuring NK/T-cell lymphoma, Methotrexate, Radiotherapy, Concurrent chemoradiation
Eligibility Criteria
Inclusion Criteria:
- Age range 18-75 years old
- Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
- ECOG performance status 0-1
- Life expectancy of more than 3 months
- Adequate bone marrow and organ functions
Exclusion Criteria:
- non-nasal NK/T-cell lymphoma
- Prior exposure of methotrexate
- With third space effusion
- Pregnant or lactating women
- 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 Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiotherapy alone
Concurrent chemoradiation
Arm Description
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
Outcomes
Primary Outcome Measures
3-year Progression-free survival
Secondary Outcome Measures
Overall response rate
3-year overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01667289
Brief Title
Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
Official Title
A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
unexpected high grade of mucositis observed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2017 (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 prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.
Detailed Description
Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.
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, Methotrexate, Radiotherapy, Concurrent chemoradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy alone
Arm Type
Active Comparator
Arm Description
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Arm Title
Concurrent chemoradiation
Arm Type
Experimental
Arm Description
Concurrent chemoradiation
Chemotherapy:
Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy alone
Intervention Description
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Intervention Type
Drug
Intervention Name(s)
Concurrent chemoradiation
Other Intervention Name(s)
MTX
Intervention Description
Concurrent chemoradiation
Chemotherapy:
Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range 18-75 years old
Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
ECOG performance status 0-1
Life expectancy of more than 3 months
Adequate bone marrow and organ functions
Exclusion Criteria:
non-nasal NK/T-cell lymphoma
Prior exposure of methotrexate
With third space effusion
Pregnant or lactating women
Serious uncontrolled diseases and intercurrent infection
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
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
12. IPD Sharing Statement
Learn more about this trial
Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
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