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Radiation Therapy in Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031668
Recruitment Status : Completed
First Posted : July 1, 2003
Last Update Posted : April 1, 2020
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy after stem cell transplantation is more effective than stem cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone autologous stem cell transplantation.

Condition or disease Intervention/treatment Phase
Lymphoma Radiation: radiation therapy Not Applicable

Detailed Description:


  • Compare the 3-year progression-free survival of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation with or without involved-field radiotherapy.
  • Compare the overall survival of patients treated with these regimens.
  • Compare 3-year progression-free disease within and outside radiotherapy fields in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to pre-salvage chemotherapy (primary refractory disease vs relapse), response to post-salvage chemotherapy (complete/unconfirmed complete vs partial), and participating center. Within 6-8 weeks after completion of autologous hematopoietic stem cell transplantation, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo involved-field radiotherapy (IFRT) 5 days a week for 3-5 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients undergo observation only. Quality of life in arm I is assessed at baseline, on day 1 of IFRT, at weeks 2 and 4 during IFRT, at 1 month, 4 months, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. Quality of life in arm II is assessed at baseline, 1 month, 2 months, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 4.2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Actual Study Start Date : January 31, 2001
Actual Primary Completion Date : February 10, 2009
Actual Study Completion Date : February 10, 2009

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-Hodgkin's lymphoma

    • Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma)
    • Previous indolent lymphoma (follicular center cell lymphoma, marginal zone lymphoma, including extranodal MALT lymphoma and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse
    • Peripheral T-cell lymphoma
    • Anaplastic large cell lymphoma (T cell or null cell)
    • Small non-cleaved Burkitt-like lymphoma
  • Relapsed or refractory disease after first-line anthracycline-based chemotherapy

    • Bulky disease, nodal or extranodal

      • Clinically or radiographically measurable mass at least 5 cm in diameter OR
    • Non-bulky disease, nodal or extranodal, excluding diffuse organ (lung, liver, kidney, or bone marrow) involvement

      • Clinically or radiographically measurable disease more than 1.5 cm in greatest transverse diameter
  • Biopsy at relapse not required except for transformed lymphomas

    • Patients with transformed lymphoma at diagnosis, but with indolent histology without transformation at relapse, are not eligible
  • No patients with stage IA or IIA disease at initial diagnosis who, at time of relapse or diagnosis of refractory disease prior to salvage therapy, remained in stage IA or IIA, with no new disease sites, without having received radiotherapy
  • Received up to 2 regimens and 4 courses of salvage chemotherapy

    • Monoclonal antibodies (e.g., rituximab) are not considered salvage chemotherapy
    • Achieved complete response (CR), unconfirmed CR, or partial response (PR) if bulky disease OR
    • Achieved PR (but not CR) if non-bulky disease
  • No residual disease involving extranodal organs diffusely (e.g., liver, lung, bone, kidney, or leptomeningeal) after salvage chemotherapy
  • Planned autologous hematopoietic stem cell transplantation (ASCT)

    • ASCT conditioning must be with high-dose BEAM (carmustine, etoposide, cytarabine, and melphalan) chemotherapy
  • No disease progression after ASCT
  • No major organ complication or poor hematologic recovery from ASCT that would preclude initiation of study radiotherapy within 14 weeks after ASCT
  • No more than 2 non-contiguous nodal or extranodal areas of bulky/residual disease requiring more than 2 separate involved-field radiotherapy volume arrangements (e.g., field arrangement covering up to 2 involved lymph node regions or extranodal sites, with or without 1 adjacent nodal/region or extranodal site)
  • No active CNS lymphoma (parenchymal brain and/or leptomeningeal)



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin


Biologic therapy:

  • See Disease Characteristics
  • No prior radioimmunotherapy


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No prior total body irradiation
  • No prior radiotherapy to the site of bulky disease or residual tumor


  • Not specified


  • No other concurrent anti-cancer therapy unless documentation of disease progression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031668

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Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
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Study Chair: Richard Tsang, MD, FRCPC Princess Margaret Hospital, Canada
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Responsible Party: NCIC Clinical Trials Group Identifier: NCT00031668    
Other Study ID Numbers: LY8
CDR0000069214 ( Other Identifier: PDQ )
First Posted: July 1, 2003    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
Waldenstrom macroglobulinemia
recurrent adult diffuse large cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases