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Spots Global Cancer Trial Database for Efficacy Study of Outpatient Therapy for Lymphoma

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Trial Identification

Brief Title: Efficacy Study of Outpatient Therapy for Lymphoma

Official Title: A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma

Study ID: NCT00163761

Study Description

Brief Summary: This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.

Detailed Description: Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Canberra Hospital, Canberra, Australian Capital Territory, Australia

Royal North Shore Hospital, Sydney, New South Wales, Australia

Mater Adult Hospital, South Brisbane, Queensland, Australia

Royal Hobart Hospital, Hobart, Tasmania, Australia

The Alfred Hospital, Melbourne, Victoria, Australia

The Royal Melbourne Hospital, Melbourne, Victoria, Australia

Frankston Hospital, Melbourne, Victoria, Australia

Monash Medical Centre, Melbourne, Victoria, Australia

Border Medical Oncology, Wodonga, Victoria, Australia

Fremantle Hospital, Fremantle, Western Australia, Australia

Contact Details

Name: Andrew Spencer, Assoc. Prof

Affiliation:

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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