National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Phase III Randomized Study of Involved-Field Radiotherapy With or Without Low-Dose Total Body Irradiation in Patients With Previously Untreated, Stage I or II Low-Grade Non-Hodgkin's Lymphoma
Last Modified: 11/10/2006     First Published: 4/1/2001  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overOtherEORTC-20971
EORTC-22997, NCT00014326

Objectives

  1. 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.
  2. Determine the response of patients treated with low-dose TBI.
  3. Compare the overall survival and quality of life of patients treated with these regimens.

Entry 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.]

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

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/mm3

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

Expected Enrollment

344

A total of 344 patients will be accrued for this study within 6 years.

Outcomes

Primary Outcome(s)

Disease-free survival

Secondary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Pierre Richaud, MD, Study coordinator
Ph: 33-5-56-33-33-20
Email: richaud@bergonie.org

Trial Sites

Belgium
  Leuven
 U.Z. Gasthuisberg
 Contact Person
Ph: 32-16-332-211
 Universitair Medisch Centrum St. Radboud - Nijmegen
 Contact Person
Ph: 31-80-361-1111
Croatia
  Zagreb
 University Hospital Rebro
 Contact Person
Ph: 385-1-233-3368
Denmark
  Copenhagen
 Rigshospitalet - Copenhagen University Hospital
 Contact Person
Ph: 45-3545-3545
Egypt
  Cairo
 National Cancer Institute of Egypt
 Contact Person
Ph: 20-2-364-3661
France
  Bayonne
 Centre D'Oncologie Du Pays-Basque
 Contact Person
Ph: 33-5-5959-3871
  Bordeaux
 Institut Bergonie
 Contact Person
Ph: 33-556-333-333
  Dax
 Centre Hospitalier de Dax
 Contact Person
Ph: 33-5-5891-4848
  Libourne
 Hopital Robert Boulin
 Contact Person
Ph: 33-5-5755-3434
  Perigueux
 Polyclinique Francheville
 Contact Person
Ph: 33-5-5306-4140
Netherlands
  Enschede
 Medisch Spectrum Twente
 Contact Person
Ph: 31-53-487-2000
  Groningen
 University Medical Center Groningen
 Contact Person
Ph: 31-50-361-6161
  Maastricht
 Maastro Clinic - Locatie Maastricht
 Contact Person
Ph: 31-43-387-4461
  Rotterdam
 Daniel Den Hoed Cancer Center at Erasmus Medical Center
 Contact Person
Ph: 31-10-439-1911
  Tilburg
 Dr. Bernard Verbeeten Instituut
 Contact Person
Ph: 31-13-594-7777

Registry Information
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
Trial Start Date 2001-01-26
Registered in ClinicalTrials.gov NCT00014326 1
Date Submitted to PDQ 2001-02-06
Information Last Verified 2009-06-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00014326