Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	SWOG-S0014 NCT00005089, S0014

Objectives

I.  Assess two year progression free survival after treatment with 
cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus 
rituximab followed by radiotherapy in patients with stage I, IE, or non-bulky 
stage II or IIE high risk localized intermediate or high grade non-Hodgkin's 
lymphoma.  

II.  Determine the toxicity of this treatment in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed stage I, IE, or non-bulky II or IIE non-Hodgkin's
lymphoma of one of the following subtypes:
 Diffuse large B-cell 
 Mantle cell
 High grade B-cell, Burkitt's or Burkitt like
 Anaplastic large cell (B-cell phenotype only)

Lymphoma must express CD20

All disease must be encompassable in a single radiation port (including any
resected disease)


Must have at least 1 of the following adverse prognostic features:
 Non-bulky stage II or non-bulky stage IIE disease
 Over 60 years of age
 Zubrod performance status of 2
 Elevated serum LDH

A new classification scheme for adult non-Hodgkin's lymphoma has been adopted
by PDQ.  The terminology of "indolent" or "aggressive" lymphoma will replace
the former terminology of "low", "intermediate", or "high" grade lymphoma. 
However, this protocol uses the former terminology.

Prior/Concurrent Therapy:

Biologic therapy:
 No prior monoclonal antibody therapy

Chemotherapy:
 No prior chemotherapy for lymphoma 

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy for lymphoma 

Surgery:
 Not specified

Patient Characteristics:

Age:
 Over 18

Performance status:
 Zubrod 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No medical contraindications to CHOP chemotherapy or rituximab
 No prior malignancy within past 5 years except adequately treated basal cell 
  or squamous cell skin cancer or carcinoma in situ of the cervix
 No AIDS or HIV
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 60 patients will be accrued for this study.

Outline

Patients receive rituximab IV on days 1 and 8 of the first course, then on day 
1 of courses 2 and 3.  Patients receive cyclophosphamide IV over 1-2 hours, 
doxorubicin IV, and vincristine IV on day 10 of the first course, then on day 
3 of courses 2 and 3.  Patients receive oral prednisone on days 10-14 of the 
first course, then on days 3-7 of courses 2 and 3.  Treatment repeats every 21 
days for 3 courses in the absence of disease progression or unacceptable 
toxicity.  Chemotherapy is followed by radiotherapy administered 5 days a week 
for 4-5 weeks.

Patients are followed every 6 months for two years, and then annually 
thereafter.

Persky DO, Unger JM, Spier CM, et al.: Phase II study of rituximab plus three cycles of CHOP and involved-field radiotherapy for patients with limited-stage aggressive B-cell lymphoma: Southwest Oncology Group study 0014. J Clin Oncol 26 (14): 2258-63, 2008.[PUBMED Abstract]

Miller TP, Unger JM, Spier C, et al.: Effect of adding rituximab to three cycles of CHOP plus involved-field radiotherapy for limited-stage aggressive diffuse B-cell lymphoma (SWOG-0014). [Abstract] Blood 104 (11): A-158, 2004.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Thomas Miller, MD, Protocol chair		Ph: 520-626-2667; 800-622-2673

Registry Information
Official Title		Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma
Trial Start Date		2000-04-01
Registered in ClinicalTrials.gov		NCT00005089
Date Submitted to PDQ		2000-02-29
Information Last Verified		2008-04-17
NCI Grant/Contract Number		CA32102