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

NCT00014326 | Terminated Phase 3

• 3 other identifiers: EORTC-20971-22997EORTC-20971EORTC-22997
• Study Type: interventional
• Target: 204
• Locations: 6 countries
• Sites: 15

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (3)

• 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

Interventions

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (15)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Leuven, B-3000, Belgium

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Centre D'Oncologie Du Pays-Basque

Bayonne, F-64100, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Hospitalier de Dax

Dax, 40107, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Maastro Clinic - Locatie Maastricht

Maastricht, NL-6229 ET, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pierre Richaud, MD

  Institut Bergonié

  STUDY CHAIR

• Marten Beijert, MD

  University Medical Center Groningen, Groningen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Primary Completion: March 1, 2009
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

BE (2); EG (1); NL (5); FR (5); DK (1); CR (1)