A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years
| ISRCTN | ISRCTN87375595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87375595 |
| ClinicalTrials.gov number | NCT00079105 |
| Secondary identifying numbers | Version 3: 20.1.2005 |
- Submission date
- 04/08/2006
- Registration date
- 18/08/2006
- Last edited
- 21/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Stephen John Proctor
Scientific
Scientific
Academic Haematology
Leech Building
Medical School
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0) 191 222 7791 |
|---|---|
| s.j.proctor@ncl.ac.uk |
Study information
| Study design | Phase II two-arm non-randomised clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.shieldstudy.co.uk/publicdocs/VEPEMBV5.doc |
| Scientific title | A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years |
| Study acronym | SHIELD Study |
| Study objectives | 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(s) | Thames Valley Multi-Centre Research Ethics Committee, reference number: 03/12/062. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2004 |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/08/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Haematology
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development
Royal Victoria Infirmary
Newcastle upon Tyne
NE2 4HH
England
United Kingdom
| Website | http://www.shieldstudy.co.uk |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
Marrow & Stem Cell Transplant 2000 (The Millennium Fund) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 21/06/2012 | Yes | No |
Editorial Notes
21/02/2019: The clinicaltrials.gov number has been added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
