NCT00031668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable lymphoma

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable lymphoma

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 1, 2003

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2009

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

8 years

First QC Date

March 8, 2002

Last Update Submit

March 30, 2020

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemiarecurrent adult diffuse large cell lymphomarecurrent adult Burkitt lymphomarecurrent adult T-cell leukemia/lymphomaanaplastic large cell lymphoma

Interventions

radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

LymphomaWaldenstrom MacroglobulinemiaLymphoma, Large B-Cell, DiffuseBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, Anaplastic

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoma, B-CellLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Richard Tsang, MD, FRCPC

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

July 1, 2003

Study Start

January 31, 2001

Primary Completion

February 10, 2009

Study Completion

February 10, 2009

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(9)