LymphomaNCT00031668
Radiation Therapy in Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
A study testing radiation therapy in people with Lymphoma, run by NCIC Clinical Trials Group at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 9 sitesCanada
- Study dates
- 31 Jan 2001to 10 Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- 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)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior radioimmunotherapy
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior total body irradiation
- No prior radiotherapy to the site of bulky disease or residual tumor
Surgery:
- Not specified
Other:
- No other concurrent anti-cancer therapy unless documentation of disease progression
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
McGill University
Montreal, Quebec, H2W 1S6
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
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)
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Lymphoma
- Being tested
- radiation therapy
- Keywords
- Waldenstrom macroglobulinemia, recurrent adult diffuse large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2003 (estimated)
- Study start31 Jan 2001
- Primary completion10 Feb 2009
- Study completion10 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Richard Tsang, MD, FRCPC, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031668
- Sponsor's protocol ID
- LY8
- Other IDs
- CAN-NCIC-LY8, CDR0000069214
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2002
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00031668
- Acronym / sponsor ID
- LY8
- Conditions
- Lymphoma
- Keywords
- Waldenstrom macroglobulinemia, recurrent adult diffuse large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 31 Jan 2001 (actual)
- Primary completion
- 10 Feb 2009 (actual)
- Study completion
- 10 Feb 2009 (actual)
- First posted
- 1 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Tsang, MD, FRCPC study chair
Princess Margaret Hospital, Canada
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation therapy in people with Lymphoma, run by NCIC Clinical Trials Group at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.