Clinical Trial: Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Trial of Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin (GIFOX-B)in Untreated NK/T Cell Lymphoma

Brief Summary:

  • Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV.
  • Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.

Detailed Summary:
Sponsor: National Cancer Centre, Singapore

Current Primary Outcome: Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT) [ Time Frame: 3 years ]

Assess the response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy together with intensity-modulated radiation therapy (IMRT) in stage IB or bulky disease - II patients and chemotherapy alone in stage III - IV patients.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients [ Time Frame: 3 years ]
  • Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients [ Time Frame: 5 years ]
  • Toxicity of bortezomib administered in combination with GIFOX chemotherapy [ Time Frame: 3 years ]
    Access the toxicity of treatment according to CTC AE 4.0


Original Secondary Outcome: Same as current

Information By: National Cancer Centre, Singapore

Dates:
Date Received: June 9, 2016
Date Started: March 2011
Date Completion:
Last Updated: September 2, 2016
Last Verified: September 2016