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Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, contiguous stage II small lymphocytic lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, nodal marginal zone B-cell lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed stage I or II, low-grade, non-Hodgkin's lymphoma Follicular lymphoma grade I, II, or III Small lymphocytic lymphoma Lymphoplasmacytoid lymphoma Nodal marginal zone lymphoma Previously untreated disease At least 1 measurable or evaluable mass at least 1.1 cm (except for patients with stage I disease where the entire mass was removed for diagnostic purposes) NOTE: 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: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 2,000/mm ^3 Platelet count greater than 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition that would preclude study participation Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No other concurrent anticancer therapy

Sites / Locations

  • U.Z. Gasthuisberg
  • Universitair Medisch Centrum St. Radboud - Nijmegen
  • University Hospital Rebro
  • Rigshospitalet - Copenhagen University Hospital
  • National Cancer Institute of Egypt
  • Centre D'Oncologie Du Pays-Basque
  • Institut Bergonie
  • Centre Hospitalier de Dax
  • Hopital Robert Boulin
  • Polyclinique Francheville
  • Medisch Spectrum Twente
  • University Medical Center Groningen
  • Maastro Clinic - Locatie Maastricht
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Dr. Bernard Verbeeten Instituut

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Overall survival
Quality of life as assessed by European Organization of Research for the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30
Response as assessed by Cheson criteria

Full Information

First Posted
April 10, 2001
Last Updated
July 13, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00014326
Brief Title
Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma
Official Title
A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized, Stages I and II, Low Grade Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
January 2001 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have low-grade stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.
Detailed Description
OBJECTIVES: Determine if the addition of low-dose total body irradiation (TBI) to involved-field radiotherapy improves the disease-free survival of patients with previously untreated, stage I or II low-grade non-Hodgkin's lymphoma. Determine the response of patients treated with low-dose TBI. Compare the overall survival and quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, stage (I vs II), performance status (0-1 vs 2), lactate dehydrogenase elevation (yes vs no), histological subtype (small lymphocytic lymphoma vs lymphoplasmacytoid lymphoma vs follicular lymphoma), and, for stage I patients, presence of measurable mass (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo involved-field radiotherapy daily five days a week for 2.5-4 weeks. Arm II: Patients undergo low-dose total body irradiation (TBI) daily 5 days a week on weeks 1 and 4. At 4 weeks after completion of TBI, patients undergo involved-field radiotherapy as in arm I. Quality of life is assessed before treatment, at 4 weeks after completion of involved-field radiotherapy, every 6 months for 5 years, and then annually thereafter. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 344 patients will be accrued for this study within 6 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, contiguous stage II small lymphocytic lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, nodal marginal zone B-cell lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Disease-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Quality of life as assessed by European Organization of Research for the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30
Title
Response as assessed by Cheson criteria

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage I or II, low-grade, non-Hodgkin's lymphoma Follicular lymphoma grade I, II, or III Small lymphocytic lymphoma Lymphoplasmacytoid lymphoma Nodal marginal zone lymphoma Previously untreated disease At least 1 measurable or evaluable mass at least 1.1 cm (except for patients with stage I disease where the entire mass was removed for diagnostic purposes) NOTE: 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: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 2,000/mm ^3 Platelet count greater than 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition that would preclude study participation Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Richaud, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marten Beijert, MD
Organizational Affiliation
University Medical Center Groningen, Groningen
Official's Role
Study Chair
Facility Information:
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Universitair Medisch Centrum St. Radboud - Nijmegen
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
University Hospital Rebro
City
Zagreb
ZIP/Postal Code
41000
Country
Croatia
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Centre D'Oncologie Du Pays-Basque
City
Bayonne
ZIP/Postal Code
F-64100
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier de Dax
City
Dax
ZIP/Postal Code
40107
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Polyclinique Francheville
City
Perigueux
ZIP/Postal Code
24004
Country
France
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Maastro Clinic - Locatie Maastricht
City
Maastricht
ZIP/Postal Code
NL-6229 ET
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands

12. IPD Sharing Statement

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Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma

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