Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01667302
First received: August 13, 2012
Last updated: March 2, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.


Condition Intervention Phase
Extranodal NK/T-cell Lymphoma, Nasal Type
Drug: Radiotherapy followed by chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 3-year Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • 3-year overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy followed by chemotherapy
Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
Drug: Radiotherapy followed by chemotherapy
Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
Other Name: DXM, IFO, VP-16, DDP, PEG-ASP

Detailed Description:

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 14-70 years old
  • Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
  • ECOG performance status 0-1
  • Life expectancy of more than 3 months
  • Without prior history of pancreatitis
  • Adequate bone marrow and organ functions

Exclusion Criteria:

  • Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
  • Pregnant or lactating women
  • With contraindication of steroid including uncontrolled diabetes
  • Serious uncontrolled diseases and intercurrent infection
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667302

Contacts
Contact: Ye Guo, MD 862164175590 pattrick_guo@msn.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
SHanghai, Shanghai, China, 200032
Contact: Ye Guo, MD    862164175590    pattrick_guo@msn.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

No publications provided

Responsible Party: Ye Guo, Assocaite Director of Medical Oncology Department, Fudan University
ClinicalTrials.gov Identifier: NCT01667302     History of Changes
Other Study ID Numbers: LMTG 12-02
Study First Received: August 13, 2012
Last Updated: March 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
NK/T-cell lymphoma
Radiotherapy
Adjuvant chemotherapy

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

ClinicalTrials.gov processed this record on August 28, 2014