Clinical trial NCT00041210: Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse-free survival
Secondary outcomes:
measure: Overall survival
measure: Toxicity
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Chichester
country: United Kingdom
facility: Saint Richards Hospital
state: England
city: Coventry
country: United Kingdom
facility: Walsgrave Hospital
state: England
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: England
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: England
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: England
city: Hemel Hempstead
country: United Kingdom
facility: Hemel Hempstead General
state: England
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: England
city: Ilford, Essex
country: United Kingdom
facility: King George Hospital
state: England
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: St. George's Hospital
state: England
city: London
country: United Kingdom
facility: University College Hospital - London
state: England
city: Norfolk
country: United Kingdom
facility: James Paget Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Portsmouth Hants
country: United Kingdom
facility: Portsmouth Oncology Centre at Saint Mary's Hospital
state: England
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Stafford
country: United Kingdom
facility: Staffordshire General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Torquay
country: United Kingdom
facility: Torbay Hospital
state: England
city: West Bromwich
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: England
city: York
country: United Kingdom
facility: Cancer Care Centre at York Hospital
state: England
city: Craigavon
country: United Kingdom
facility: Craigavon Area Hospital
state: Northern Ireland
city: Airdrie
country: United Kingdom
facility: Monklands General Hospital
state: Scotland
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Institute
state: Wales
Study officials:
affiliation: Mount Vernon Cancer Centre at Mount Vernon Hospital
name: Peter J. Hoskin, MD
role: STUDY_CHAIR
References: