Stage I/II Extranodal NK/T-cell LymphomaPhase 2NCT02276248
Radiotherapy Combined With GDP Chemotherapy in Stage I/II Extranodal Natural Killer/T-cell Lymphoma
A Phase 2 study testing Intensity-modulated radiation therapy and GDP chemotherapy in people with Stage I/II Extranodal NK/T-cell Lymphoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of radiotherapy combined with GDP (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural killer/T-cell lymphoma patients with unfavorable prognostic factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I/II Extranodal NK/T-cell Lymphoma
- What is being tested?
- Intensity-modulated radiation therapy and GDP chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of ENKTL with typical morphology and immunophenotype according to the 2008 World Health Organization classification of lymphomas;
- newly-diagnosed patients;
- tumors primarily occurring in the upper aerodigestive tract (nasal cavity, nasopharynx, oral cavity, oropharynx and hypopharynx);
- Ann Arbor stage I/II;
- age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
Show all 11Show fewer
- at least one measurable lesion;
- adequate hematologic, hepatic, and renal functions: absolute neutrophil count ≥ 1.5×109/l, platelet count ≥ 100×109/l, total bilirubin ≤ 1.5 × upper limit of normal, AST and ALT ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
- with at least one unfavorable prognostic factor (age > 60 years; B symptoms; elevated lactate dehydrogenase; regional node involvement; local tumor invasion: bone or skin; histologic elevation of high Ki-67 staining)
- life expectancy of more 3 months;
- informed consent.
Who cannot join
- patients who received prior treatment;
- stage I/II patients without unfavorable prognostic factors;
- tumors primarily occurring in the extra-upper aerodigestive tract (e.g., skin, testis, intestine, muscle and so on);
- pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
- patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
- patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- systemic anticancer therapy within 30 days before inclusion in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, 100021
About this study
Official title: Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy in Stage I/II Extranodal Natural Killer/T-cell Lymphoma Patients With Unfavorable Prognostic Factors: an Open-label, Single-arm, Phase II Clinical Trial
This study is to evaluate the efficacy and safety of radiotherapy combined with GDP (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural killer/T-cell lymphoma patients with unfavorable prognostic factors.
Read the detailed description
Radiotherapy has been recognized as the definitive treatment of choice for stages I and II extranodal NK/T cell lymphoma. The progression-free survival rate and overall survival rate of radiotherapy plus anthracycline-containing chemotherapy were comparable to that of radiotherapy alone. Our previous studies demonstrated the high responsiveness and safety of GDP (gemcitabine, cisplatin, dexamethasone) regimen in patients with extranodal NK/T cell lymphoma. Therefore, we design this study to evaluate the safety and benefit of radiotherapy plus GDP regimen in extranodal NK/T cell lymphoma.
- Conditions
- Stage I/II Extranodal NK/T-cell Lymphoma
- Being tested
- Intensity-modulated radiation therapy, GDP chemotherapy
- 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.
Intensity-modulated radiation therapyRadiation
total dose: 50 to 56 grays per fraction: 2 grays
GDP chemotherapyDrug
gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy+chemotherapy | Experimental | Radiotherapy technique: Intensity-modulated radiation therapy total dose: 50 to 56 grays per fraction: 2 grays GDP chemotherapy: gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days. Receives: Radiation: Intensity-modulated radiation therapy; Drug: GDP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival
Measured: 2 year
Secondary outcomes (2)
2-year overall survival
Measured: 2 year
number of patients with adverse events
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJun 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage I/II Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Dong, Chinese Academy of Medical Sciences
- Investigators
- Mei Dong, Principal investigator, Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276248
- Sponsor's protocol ID
- GREEN
- Status last verified
- Aug 2017
- First submitted
- 23 Oct 2014
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Qi F, Wang WH, He XH, Chen B, Gui L, Fang H, Liu P, Wang SL, Yang JL, Song YW, Yang S, Qi SN, Zhou SY, Li YX, Dong M. Phase 2 Study of First-line Intensity Modulated Radiation Therapy Followed by Gemcitabine, Dexamethasone, and Cisplatin for High-Risk, Early Stage Extranodal Nasal-Type NK/T-Cell Lymphoma: The GREEN Study. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):61-70. doi: 10.1016/j.ijrobp.2018.05.046. Epub 2018 May 29.
PubMed 30102205
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy in Stage I/II Extranodal Natural Killer/T-cell Lymphoma Patients With Unfavorable Prognostic Factors: an Open-label, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02276248
- Acronym / sponsor ID
- GREEN
- Conditions
- Stage I/II Extranodal NK/T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Oct 2014 (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.
This study is to evaluate the efficacy and safety of radiotherapy combined with GDP (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural killer/T-cell lymphoma patients with unfavorable prognostic factors.
Detailed description
Radiotherapy has been recognized as the definitive treatment of choice for stages I and II extranodal NK/T cell lymphoma. The progression-free survival rate and overall survival rate of radiotherapy plus anthracycline-containing chemotherapy were comparable to that of radiotherapy alone. Our previous studies demonstrated the high responsiveness and safety of GDP (gemcitabine, cisplatin, dexamethasone) regimen in patients with extranodal NK/T cell lymphoma. Therefore, we design this study to evaluate the safety and benefit of radiotherapy plus GDP regimen in extranodal NK/T cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy+chemotherapy | Experimental | Radiation: Intensity-modulated radiation therapy, Drug: GDP chemotherapyRadiotherapy technique: Intensity-modulated radiation therapy total dose: 50 to 56 grays per fraction: 2 grays GDP chemotherapy: gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- diagnosis of ENKTL with typical morphology and immunophenotype according to the 2008 World Health Organization classification of lymphomas;
- newly-diagnosed patients;
- tumors primarily occurring in the upper aerodigestive tract (nasal cavity, nasopharynx, oral cavity, oropharynx and hypopharynx);
- Ann Arbor stage I/II;
- age ≥ 18 years;
Key exclusion criteria (8 listed)
- patients who received prior treatment;
- stage I/II patients without unfavorable prognostic factors;
- tumors primarily occurring in the extra-upper aerodigestive tract (e.g., skin, testis, intestine, muscle and so on);
- pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
- patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
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 |
|---|---|---|
| Intensity-modulated radiation therapytotal dose: 50 to 56 grays per fraction: 2 grays | Radiation | radiotherapy+chemotherapy |
| GDP chemotherapygemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days. | Drug | radiotherapy+chemotherapy |
Primary outcome
2-year progression-free survival
Time frame: 2 year
2 secondary outcomes
2-year overall survival
Time frame: 2 year
number of patients with adverse events
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Derived from this study: PubMed 30102205Qi F, Wang WH, He XH, Chen B, Gui L, Fang H, Liu P, Wang SL, Yang JL, Song YW, Yang S, Qi SN, Zhou SY, Li YX, Dong M. Phase 2 Study of First-line Intensity Modulated Radiation Therapy Followed by Gemcitabine, Dexamethasone, and Cisplatin for High-Risk, Early Stage Extranodal Nasal-Type NK/T-Cell Lymphoma: The GREEN Study. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):61-70. doi: 10.1016/j.ijrobp.2018.05.046. Epub 2018 May 29.
Related trials for Stage I/II Extranodal NK/T-cell Lymphoma
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
RecruitingObservational study
Registry of Older Patients With Cancer
Chronic Myeloproliferative Disorders, Cognitive/Functional Effects
Not yet recruitingPhase 2
A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
NKTCL
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.
Mei Dong principal investigator
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
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 Intensity-modulated radiation therapy and GDP chemotherapy in people with Stage I/II Extranodal NK/T-cell Lymphoma, run by Chinese Academy of Medical Sciences 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 16 Aug 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2-year progression-free survival (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02276248, which also lists 1 linked publication.
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 16 Aug 2017.