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

Phase 2

Terminated

• Conditions: Extranodal NK-T-CELL LYMPHOMA
• Interventions: Drug: GIFOX-Bortezomib; Radiation: IMRT

• Registration Number: NCT02808091
• Lead Sponsor: National Cancer Centre, Singapore

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 Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early stage (IB or bulky disease - II)	IMRT	who will receive GIFOX-B chemotherapy followed by involved field radiotherapy.
Advanced stage (III - IV)	GIFOX-Bortezomib	will receive only chemotherapy alone
Early stage (IB or bulky disease - II)	GIFOX-Bortezomib	who will receive GIFOX-B chemotherapy followed by involved field radiotherapy.

Primary Outcome Measures

Name	Time	Method
Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Centre; 🇸🇬 Singapore, Singapore