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

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014326

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Quality of life as assessed by European Organization of Research for the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 [ Designated as safety issue: No ]
Response as assessed by Cheson criteria [ Designated as safety issue: No ]

Estimated Enrollment:	344
Study Start Date:	January 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014326

Locations

Belgium
U.Z. Gasthuisberg	Recruiting
Leuven, Belgium, B-3000
Contact: Contact Person 32-16-332-211
Universitair Medisch Centrum St. Radboud - Nijmegen	Recruiting
Leuven, Belgium, B-3000
Contact: Contact Person 31-80-361-1111
Croatia
University Hospital Rebro	Recruiting
Zagreb, Croatia, 41000
Contact: Contact Person 385-1-233-3368
Denmark
Rigshospitalet - Copenhagen University Hospital	Recruiting
Copenhagen, Denmark, 2100
Contact: Contact Person 45-3545-3545
Egypt
National Cancer Institute of Egypt	Recruiting
Cairo, Egypt
Contact: Contact Person 20-2-364-3661
France
Centre D'Oncologie Du Pays-Basque	Recruiting
Bayonne, France, F-64100
Contact: Contact Person 33-5-5959-3871
Centre Hospitalier de Dax	Recruiting
Dax, France, 40107
Contact: Contact Person 33-5-5891-4848
Hopital Robert Boulin	Recruiting
Libourne, France, 33500
Contact: Contact Person 33-5-5755-3434
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Contact Person 33-556-333-333
Polyclinique Francheville	Recruiting
Perigueux, France, 24004
Contact: Contact Person 33-5-5306-4140
Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center	Recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Contact Person 31-10-439-1911
University Medical Center Groningen	Recruiting
Groningen, Netherlands, 9700 RB
Contact: Contact Person 31-50-361-6161
Maastro Clinic - Locatie Maastricht	Recruiting
Maastricht, Netherlands, NL-6229 ET
Contact: Contact Person 31-43-387-4461
Medisch Spectrum Twente	Recruiting
Enschede, Netherlands, 7500 KA
Contact: Contact Person 31-53-487-2000
Dr. Bernard Verbeeten Instituut	Recruiting
Tilburg, Netherlands, 5042 SB
Contact: Contact Person 31-13-594-7777

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Pierre Richaud, MD

Institut Bergonie

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068532, EORTC-20971, EORTC-22997
Study First Received:	April 10, 2001
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00014326 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009