ISRCTN - ISRCTN87375595: A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-vepemb-chemotherapy-for-patients-over-60-years-old-with-hodgkins-lymphoma

Trial website

http://www.shieldstudy.co.uk

Contact information

Type

Scientific

Primary contact

Prof Stephen John Proctor

ORCID ID

Contact details

Academic Haematology
Leech Building
Medical School
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0) 191 222 7791
s.j.proctor@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 3: 20.1.2005

Study information

Scientific title

Acronym

SHIELD Study

Study hypothesis

Progress in the treatment of Hodgkins Lymphoma (HL) in patients under 60 years has been substantial but in the over 60 years age group only small studies have been conducted and limited progress in outcome has been seen. It is necessary to create a starting point of uniform treatment for HL in the over 60 years age group, giving potentially curative treatment in a form that would be acceptable to individuals in this age group.

Nationally and internationally there is no existing co-ordinated study of HL in this age group and recent data indicates that outcome has not improved in the last 15 years. A number of older patients with HL fail to enter clinical trials as they are "not fit" for multiple drug chemotherapy. This study will aim to register all pathologically eligible patients in participating centres in order to provide a clearer overall clinical picture of this disease, whether or not they undergo protocol chemotherapy.

This study is of a phase II nature that aims to assess the efficacy, toxicity and applicability of the Vinblastine, Endoxana (cyclophosphamide), Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin (VEPEMB) chemotherapy schedule in this particular patient population, as a prelude to a subsequent randomised trial. The linking of this phase II study with total data collection aims to assess:
1. The proportions of patients who can enter a study of curative intent within this age group.
2. To assess complete response rate, event free survival and overall survival following this treatment schedule.

Please note that, as of 12/12/2008, the anticipated end date of this trial has been updated from 31/08/2007 to 31/08/2009.

Ethics approval

Thames Valley Multi-Centre Research Ethics Committee, reference number: 03/12/062.

Study design

Phase II two-arm non-randomised clinical study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.shieldstudy.co.uk/publicdocs/VEPEMBV5.doc

Condition

Hodgkin's lymphoma

Intervention

The patient either receives the VEPEMB treatment or is simply registered on the database and the alternative treatment which they receive is recorded. The patient's treatment is determined by their physicians who assess their 'fragility'. If they are too 'fragile' they will not be given the VEPEMB regimen.

Intervention type

Drug

Phase

Phase II

Drug names

Vinblastine, Endoxana (cyclophosphamide), Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin

Primary outcome measure

The primary endpoints will be progression-free survival, with clinical progression and death as the events. On suspicion of progression (e.g. new or enlarging masses, development of B symptoms) patients should be re-evaluated according to normal procedures to confirm relapse. Histological confirmation of relapse is recommended but not mandatory.

Survival time, including death from any cause, will also be investigated. For both endpoints, the event-free times will be dated from the date of histological diagnosis.

Secondary outcome measures

Analysis will be done to assess potential prognostic factors (Epstein-Barr Virus [EBV] status, "Fragility" assessment, Hasenclever index, soluble form of the CD30 molecule [sCD30]) which might be relevant in this age group.

Overall trial start date

01/09/2004

Overall trial end date

31/08/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Histologically confirmed classical Hodgkin's Lymphoma (HL)
2. No previous treatment for HL
3. Aged over 60
4. "Non fragile" patients, i.e. patients mental and physical status must be sufficient to withstand the treatment described
5. No concomitant neoplasia or known Human Immunodeficiency Virus (HIV) infection
6. Written informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Nodular Lymphocyte Predominance Hodgkin's Lymphoma (NLPHL)
2. Aged under 60
3. Patient previously treated for HL
4. Known HIV infection or concomitant neoplasia
5. "Fragile patient" or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy
6. Unable to give informed consent

Recruitment start date

01/09/2004

Recruitment end date

31/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Haematology
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle Hospitals NHS Trust (UK)

Sponsor details

Research & Development
Royal Victoria Infirmary
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor type

Government

Website