S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00005089
First received: April 6, 2000
Last updated: May 8, 2014
Last verified: May 2014

April 6, 2000
May 8, 2014
April 2000
November 2004   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: every 6 weeks while on protocol treatment, then every 6 months for 2 years, then annually thereafter ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00005089 on ClinicalTrials.gov Archive Site
Not Provided
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S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.

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.

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.

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

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: rituximab
    375 mg/m^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.
  • Drug: cyclophosphamide
    750 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
  • Drug: doxorubicin hydrochloride
    50 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
  • Drug: prednisone
    100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.
  • Drug: vincristine sulfate
    1.4 mg/m^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.
  • Radiation: radiation therapy
    4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
Experimental: CHOP + Rituximab + RT
3 21-day cycles of CHOP (cyclophosphamide 750 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2, prednisone 100 mg x 5 days) + Rituximab 375 mg/m^2 (x 2 days for cycle 1, x 3 days for cycles 2-3). RT 4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
Interventions:
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
71
January 2017
November 2004   (final data collection date for primary outcome measure)

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.

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

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005089
CDR0000067707, S0014, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Thomas P. Miller, MD University of Arizona
Southwest Oncology Group
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP