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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00014326
• Other study ID #: EORTC-20971-22997
• Secondary ID: EORTC-20971EORTC
• Status: Terminated
• Phase: Phase 3
• First received: April 10, 2001
• Last updated: July 13, 2012
• Start date: January 2001

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 204
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Universitair Medisch Centrum St. Radboud - Nijmegen	Leuven
Croatia	University Hospital Rebro	Zagreb
Denmark	Rigshospitalet - Copenhagen University Hospital	Copenhagen
Egypt	National Cancer Institute of Egypt	Cairo
France	Centre D'Oncologie Du Pays-Basque	Bayonne
France	Institut Bergonie	Bordeaux
France	Centre Hospitalier de Dax	Dax
France	Hopital Robert Boulin	Libourne
France	Polyclinique Francheville	Perigueux
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastro Clinic - Locatie Maastricht	Maastricht
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Croatia,  Denmark,  Egypt,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival			No
Secondary	Overall survival			No
Secondary	Quality of life as assessed by European Organization of Research for the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30			No
Secondary	Response as assessed by Cheson criteria			No