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

NCT02276248 | Completed Phase 2 DMC

• 1 other identifier: GREEN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I/II Extranodal NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival

  2 year

Secondary Outcomes (2)

• 2-year overall survival

  2 year

• number of patients with adverse events

  2 year

Study Arms (1)

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.

Radiation: Intensity-modulated radiation therapy; Drug: GDP chemotherapy

Interventions

Intensity-modulated radiation therapy RADIATION

total dose: 50 to 56 grays per fraction: 2 grays

radiotherapy+chemotherapy

GDP chemotherapy DRUG

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.

radiotherapy+chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• 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.

  PMID: 30102205 DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Mei Dong

  Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 28, 2014
• Study Start: June 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

CN (1)