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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. completion date
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


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
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