LymphomaPhase 3NCT00002987
Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease
A Phase 3 study testing bleomycin sulfate, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Medical Research Council at 18 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jan 1997to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven stage IA or IIA Hodgkin's disease without mediastinal bulk Patients with Hodgkin's disease existing below diaphragm only are not eligible
PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not HIV positive No prior malignancy other than basal cell carcinoma or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY: No prior treatment
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United Kingdom17 sites
University Birmingham
Birmingham, England, B15 2TT
Bristol Royal Hospital for Sick Children
Bristol, England, BS2 8BJ
Bristol Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Royal Hospital for Sick Children
Edinburgh, Scotland
Cookridge Hospital
Leeds, England, LS16 6QB
University Hospitals of Leicester
Leicester, England, LE1 5WW
Middlesex Hospital- Meyerstein Institute
London, England, W1G 3AA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Royal Preston Hospital
Preston, PR2 9HT
Royal Marsden Hospital
Sutton, England, SM2 5PT
Southend General Hospital
Westcliff-on-Sea, England
About this study
Official title: Minimal Initial Therapy (MIT) for "Early" Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkin's disease.
Read the detailed description
OBJECTIVES: I. Determine the recurrence rate and long term survival of patients with early stage Hodgkin's disease given vincristine/doxorubicin/prednisolone/ etoposide/cyclophosphamide/bleomycin (VAPEC-B) chemotherapy and involved field radiation vs mantle radiotherapy.
OUTLINE: This is a randomized multicenter study. Patients are randomized to receive either vincristine/doxorubicin/prednisolone/etoposide/cyclophosphamide/ bleomycin (VAPEC-B) chemotherapy and involved field radiotherapy or mantle radiotherapy only. Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6, doxorubicin IV along with cyclophosphamide IV on week 1, doxorubicin IV and etoposide orally for 5 days on week 3, and vincristine and bleomycin IV on weeks 2 and 4. Involved field radiotherapy is commenced at week 6, within 14 to 21 days of the last chemotherapy treatment. Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks. Patients are followed every 3 months for the first two years, every 4 months for the third year, every 6 months for the fourth and fifth years and annually thereafter.
PROJECTED ACCRUAL: 400 patients will be accrued over 4-5 years.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, cyclophosphamide, doxorubicin hydrochloride, etoposide, prednisolone
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
cyclophosphamideDrug
etoposideDrug
prednisoloneDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2004 (estimated)
- Study startJan 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Michael Williams, MD, Study chair, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002987
- Sponsor's protocol ID
- CDR0000065522
- Other IDs
- MRC-UKLG-LY07, EU-97004
- Status last verified
- Mar 2005
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
Radford JA, Williams MV, Hancock BW, et al.: Minimal initial chemotherapy plus involved field radiotherapy (RT) vs. mantle field RT for clinical stage IA/IIA supra-diaphragmatic Hodgkin's disease (HD). Results of the UK Lymphoma Group LY07 trial. [Abstract] Eur J Haematol 73 (Suppl 65): A-E08, 39, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Initial Therapy (MIT) for "Early" Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy
- ClinicalTrials.gov ID
- NCT00002987
- Acronym / sponsor ID
- CDR0000065522
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Jan 1997
- First posted
- 6 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkin's disease.
Detailed description
OBJECTIVES: I. Determine the recurrence rate and long term survival of patients with early stage Hodgkin's disease given vincristine/doxorubicin/prednisolone/ etoposide/cyclophosphamide/bleomycin (VAPEC-B) chemotherapy and involved field radiation vs mantle radiotherapy.
OUTLINE: This is a randomized multicenter study. Patients are randomized to receive either vincristine/doxorubicin/prednisolone/etoposide/cyclophosphamide/ bleomycin (VAPEC-B) chemotherapy and involved field radiotherapy or mantle radiotherapy only. Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6, doxorubicin IV along with cyclophosphamide IV on week 1, doxorubicin IV and etoposide orally for 5 days on week 3, and vincristine and bleomycin IV on weeks 2 and 4. Involved field radiotherapy is commenced at week 6, within 14 to 21 days of the last chemotherapy treatment. Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks. Patients are followed every 3 months for the first two years, every 4 months for the third year, every 6 months for the fourth and fifth years and annually thereafter.
PROJECTED ACCRUAL: 400 patients will be accrued over 4-5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bleomycin sulfate | Biological | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| prednisolone | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Results publicationRadford JA, Williams MV, Hancock BW, et al.: Minimal initial chemotherapy plus involved field radiotherapy (RT) vs. mantle field RT for clinical stage IA/IIA supra-diaphragmatic Hodgkin's disease (HD). Results of the UK Lymphoma Group LY07 trial. [Abstract] Eur J Haematol 73 (Suppl 65): A-E08, 39, 2004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Williams, MD study chair
Cambridge University Hospitals NHS Foundation Trust
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bleomycin sulfate, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Medical Research Council at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.