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

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Steroids

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Large-cell Burkitt Lymphoma Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

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 ]


Enrollment:	71
Study Start Date:	April 2000
Estimated Study Completion Date:	January 2017
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.

Arms

Assigned Interventions

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.

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.

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005089

Show 92 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	Thomas P. Miller, MD	University of Arizona

More Information

Publications:

Persky DO, Unger JM, Spier CM, Stea B, LeBlanc M, McCarty MJ, Rimsza LM, Fisher RI, Miller TP; Southwest Oncology Group. 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. 2008 May 10;26(14):2258-63. doi: 10.1200/JCO.2007.13.6929. Epub 2008 Apr 14.

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.


Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00005089 History of Changes
Other Study ID Numbers:	CDR0000067707 S0014 U10CA032102
Study First Received:	April 6, 2000
Last Updated:	September 15, 2015
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:


stage I adult diffuse large cell lymphoma stage I adult Burkitt lymphoma stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma contiguous stage II adult diffuse large cell lymphoma	contiguous stage II adult Burkitt lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult Burkitt lymphoma

Additional relevant MeSH terms:


Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Liposomal doxorubicin Doxorubicin Prednisone Vincristine Immunosuppressive Agents	Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones

ClinicalTrials.gov processed this record on September 23, 2016