Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT01667289
Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
A Phase 2 study testing Radiotherapy alone and Concurrent chemoradiation in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- What is being tested?
- Radiotherapy alone and Concurrent chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
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.
Read the 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.
- Being tested
- Radiotherapy alone, Concurrent chemoradiation
- Keywords
- NK/T-cell lymphoma, Methotrexate, Radiotherapy, Concurrent chemoradiation
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy aloneRadiation
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Concurrent chemoradiationDrug
Also called MTX
Concurrent chemoradiation
Chemotherapy:
Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy alone | Active comparator | Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy Receives: Radiation: Radiotherapy alone |
| Concurrent chemoradiation | Experimental | Concurrent chemoradiation
Chemotherapy:
Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy Receives: Radiation: Radiotherapy alone; Drug: Concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Progression-free survival
Measured: 3 years
Secondary outcomes (2)
Overall response rate
Measured: 3 years
3-year overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: unexpected high grade of mucositis observed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Guo, Fudan University
- Investigators
- Ye Guo, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667289
- Sponsor's protocol ID
- LMTG 12-01
- Status last verified
- Mar 2013
- First submitted
- 13 Aug 2012
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01667289
- Acronym / sponsor ID
- LMTG 12-01
- Keywords
- NK/T-cell lymphoma, Methotrexate, Radiotherapy, Concurrent chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unexpected high grade of mucositis observed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy alone | Active comparator | Radiation: Radiotherapy aloneRadiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy |
| Concurrent chemoradiation | Experimental | Radiation: Radiotherapy alone, Drug: Concurrent chemoradiationConcurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- non-nasal NK/T-cell lymphoma
- Prior exposure of methotrexate
- With third space effusion
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy aloneRadiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy | Radiation | Concurrent chemoradiation, Radiotherapy alone |
| Concurrent chemoradiationAlso: MTXConcurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy | Drug | Concurrent chemoradiation |
Primary outcome
3-year Progression-free survival
Time frame: 3 years
2 secondary outcomes
Overall response rate
Time frame: 3 years
3-year overall survival
Time frame: 3 years
Results and safety
The study was stopped early (reason given: unexpected high grade of mucositis observed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Guo, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy alone and Concurrent chemoradiation in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: unexpected high grade of mucositis observed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013; AzTrials last refreshed its copy on 6 Nov 2026.