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

• ClinicalTrials.gov Identifier: NCT02276248
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: August 16, 2017
• Sponsor: Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): Mei Dong, Chinese Academy of Medical Sciences

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Mei Dong; Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: August 16, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

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