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 ]
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