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

Sponsor

Mount Vernon Cancer Centre at Mount Vernon Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00041210

Collaborator

(none)

850

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

850 participants

Allocation:

Randomized

Primary Purpose:

Treatment

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 :

Oct 1, 2001

Outcome Measures

Primary Outcome Measures

Relapse-free survival []

Secondary Outcome Measures

Overall survival []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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