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Radiotherapy Combined With GDP Chemotherapy in Stage I/II Extranodal Natural Killer/T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276248
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Mei Dong, Chinese Academy of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Stage I/II Extranodal NK/T-cell Lymphoma Radiation: Intensity-modulated radiation therapy Drug: GDP chemotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: radiotherapy+chemotherapy
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.
Radiation: Intensity-modulated radiation therapy
total dose: 50 to 56 grays per fraction: 2 grays

Drug: 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.




Primary Outcome Measures :
  1. 2-year progression-free survival [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. 2-year overall survival [ Time Frame: 2 year ]
  2. number of patients with adverse events [ Time Frame: 2 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of ENKTL with typical morphology and immunophenotype according to the 2008 World Health Organization classification of lymphomas;
  2. newly-diagnosed patients;
  3. tumors primarily occurring in the upper aerodigestive tract (nasal cavity, nasopharynx, oral cavity, oropharynx and hypopharynx);
  4. Ann Arbor stage I/II;
  5. age ≥ 18 years;
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  7. at least one measurable lesion;
  8. 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;
  9. 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)
  10. life expectancy of more 3 months;
  11. informed consent.

Exclusion Criteria:

  1. patients who received prior treatment;
  2. stage I/II patients without unfavorable prognostic factors;
  3. tumors primarily occurring in the extra-upper aerodigestive tract (e.g., skin, testis, intestine, muscle and so on);
  4. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
  5. 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)
  6. patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
  7. 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
  8. systemic anticancer therapy within 30 days before inclusion in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276248


Locations
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China, Beijing
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Mei Dong Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mei Dong, Department of Medical Oncology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02276248    
Other Study ID Numbers: GREEN
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin