Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

September 19, 2013 updated by: Mount Vernon Cancer Centre at Mount Vernon Hospital

Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
  • Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.

All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Basildon, England, United Kingdom, SS16 5NL
        • Basildon University Hospital
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Canterbury, England, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Chichester, England, United Kingdom, P019 4SE
        • Saint Richards Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Doncaster, England, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
      • Dudley, England, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Hemel Hempstead, England, United Kingdom, HP2 4AD
        • Hemel Hempstead General
      • Hull, England, United Kingdom, HU3 2KZ
        • Hull Royal Infirmary
      • Ilford, Essex, England, United Kingdom, IG3 8YB
        • King George Hospital
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospital
      • Liverpool, England, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SW17 ORE
        • St. George's Hospital
      • London, England, United Kingdom, WC1E 6AU
        • University College Hospital - London
      • Norfolk, England, United Kingdom, NR31 6LA
        • James Paget Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Portsmouth Hants, England, United Kingdom, PO3 6AD
        • Portsmouth Oncology Centre at Saint Mary's Hospital
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stafford, England, United Kingdom, ST16 3SA
        • Staffordshire General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • West Bromwich, England, United Kingdom, B71 4HJ
        • City Hospital - Birmingham
      • Wolverhampton, England, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worthing, England, United Kingdom, BN11 2DH
        • Worthing Hospital
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital
    • Northern Ireland
      • Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital
    • Scotland
      • Airdrie, Scotland, United Kingdom, ML6 0JF
        • Monklands General Hospital
      • Wakefield, Scotland, United Kingdom, WF1 4DG
        • Pinderfields General Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital
      • Swansea, Wales, United Kingdom, SA2 8QA
        • South West Wales Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma (any sub-type)

    • Stage IB, IIB, IIIA, IIIB, or IV OR
    • Stage IA or IIA with locally extensive disease (e.g., bulky mediastinal disease (e.g., greater than 0.33 of the maximum transthoracic diameter on routine chest X-ray or at least 2 extranodal sites of disease))

PATIENT CHARACTERISTICS:

Age:

  • 18 to 60

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Complete blood count normal unless directly due to Hodgkin's lymphoma

Hepatic:

  • Hepatic function normal unless directly due to Hodgkin's lymphoma

Renal:

  • Renal function normal unless directly due to Hodgkin's lymphoma

Cardiovascular:

  • No pre-existing cardiac disease

Pulmonary:

  • No pre-existing pulmonary disease

Other:

  • Not pregnant
  • Fertile patients must use effective contraception during and for six months after study
  • HIV negative
  • No other prior malignancy except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior therapy for Hodgkin's lymphoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relapse-free survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Vernon Cancer Centre at Mount Vernon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069453
  • BNLI-STANFORDV
  • EU-20206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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