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

August 13, 2012
March 2, 2013
June 2012
December 2013   (final data collection date for primary outcome measure)
3-year Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01667302 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Extranodal NK/T-cell Lymphoma, Nasal Type
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
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
Intervention: Drug: Radiotherapy followed by chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2016
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Ye Guo, MD 862164175590 pattrick_guo@msn.com
China
 
NCT01667302
LMTG 12-02
No
Ye Guo, Fudan University
Fudan University
Not Provided
Principal Investigator: Ye Guo, MD Fudan University
Fudan University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP