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

This study is currently recruiting participants.
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
History of Changes
  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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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
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 June 18, 2013