Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00041210|
Recruitment Status : Unknown
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: bleomycin sulfate Drug: ABVD regimen Drug: Stanford V regimen Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: radiation therapy||Phase 3|
- 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 (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Official Title:||Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease|
|Study Start Date :||October 2001|
- Relapse-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041210
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Royal United Hospital|
|Bath, England, United Kingdom, BA1 3NG|
|Kent and Canterbury Hospital|
|Canterbury, England, United Kingdom, CT1 3NG|
|Saint Richards Hospital|
|Chichester, England, United Kingdom, P019 4SE|
|Coventry, England, United Kingdom, CV2 2DX|
|Doncaster Royal Infirmary|
|Doncaster, England, United Kingdom, DN2 5LT|
|Russells Hall Hospital|
|Dudley, England, United Kingdom, DY1 2HQ|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|Hemel Hempstead General|
|Hemel Hempstead, England, United Kingdom, HP2 4AD|
|Hull Royal Infirmary|
|Hull, England, United Kingdom, HU3 2KZ|
|King George Hospital|
|Ilford, Essex, England, United Kingdom, IG3 8YB|
|Lincoln County Hospital|
|Lincoln, England, United Kingdom, LN2 5QY|
|Royal Liverpool University Hospital|
|Liverpool, England, United Kingdom, L7 8XP|
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|St. George's Hospital|
|London, England, United Kingdom, SW17 ORE|
|University College Hospital - London|
|London, England, United Kingdom, WC1E 6AU|
|James Paget Hospital|
|Norfolk, England, United Kingdom, NR31 6LA|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Plymouth, England, United Kingdom, PL6 8DH|
|Portsmouth Oncology Centre at Saint Mary's Hospital|
|Portsmouth Hants, England, United Kingdom, PO3 6AD|
|Romford, England, United Kingdom, RM7 OBE|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Staffordshire General Hospital|
|Stafford, England, United Kingdom, ST16 3SA|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Torquay, England, United Kingdom, TQ2 7AA|
|City Hospital - Birmingham|
|West Bromwich, England, United Kingdom, B71 4HJ|
|New Cross Hospital|
|Wolverhampton, England, United Kingdom, WV10 0QP|
|Worthing, England, United Kingdom, BN11 2DH|
|Cancer Care Centre at York Hospital|
|York, England, United Kingdom, Y031 8HE|
|Craigavon Area Hospital|
|Craigavon, Northern Ireland, United Kingdom, BT63 5QQ|
|Monklands General Hospital|
|Airdrie, Scotland, United Kingdom, ML6 0JF|
|Pinderfields General Hospital|
|Wakefield, Scotland, United Kingdom, WF1 4DG|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|South West Wales Cancer Institute|
|Swansea, Wales, United Kingdom, SA2 8QA|
|Study Chair:||Peter J. Hoskin, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|