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Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma Clinical research trials and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma. Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma  Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
For Condition: adult non-Hodgkin's lymphoma,grade 2 follicular lymphoma,grade 3 follicular lymphoma,grade 1 follicular lymphoma
Status: Recruiting
Sponsor(s): EORTC Lymphoma Cooperative Group , EORTC Radiotherapy Cooperative Group
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.
Details: OBJECTIVES: - Determine if the addition of low-dose total body irradiation (TBI) to involved-field radiotherapy improves the outcome of 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 3.5-4 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
J.H.Meerwaldt, , Medisch Spectrum Twente
Intitute Department of Medicine *Recruiting*
Prague 2, , 128 08
Czech Republic
Recruiting Contact Person 420-2-496-1111
Catharina Ziekenhuis *Recruiting*
Eindhoven, , 5602 ZA
Netherlands
Recruiting Contact Person 31-40-239-9111
Medisch Spectrum Twente *Recruiting*
ENSCHEDE, , 7500 KA
Netherlands
Recruiting Contact Person 31-53-487-2000
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9700 RB
Netherlands
Recruiting Contact Person 31-50-361-6161
National Cancer Institute of Egypt *Recruiting*
Cairo, ,
Egypt
Recruiting Contact Person 20-2-364-3661
University Hospital Rebro *Recruiting*
Zagreb, , 41000
Croatia
Recruiting Contact Person 385-1-233-3368
Polyclinique de Francheville *Recruiting*
Perigueux, , 24004
France
Recruiting Contact Person 33-5-5306-4140
Centre Hospitalier de Dax *Recruiting*
Dax, , 40107
France
Recruiting Contact Person 33-5-5891-4848
Centre D'Oncologie Du Pays-Basque *Recruiting*
Bayonne, , F-64100
France
Recruiting Contact Person 33-5-5959-3871
Radiotherapeutisch Instituut Limburg-Maastricht *Recruiting*
Maastricht, , NL-6229 ET
Netherlands
Recruiting Contact Person 31-43-387-4461
Hopital Robert Boulin *Recruiting*
Libourne, , 33500
France
Recruiting Contact Person 33-5-5755-3434
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3508 GA
Netherlands
Recruiting Contact Person 31-30-250-9111
Spedali Civili *Recruiting*
Brescia, , 25124
Italy
Recruiting Contact Person 39-399-5483
Institute of Oncology - Clinical Center University of Sarajevo *Recruiting*
Sarajevo, , 71000
Bosnia and Herzegovina
Recruiting Contact Person 387-71-3344-4800
University Medical Center Nijmegen *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 31-80-361-1111
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Contact Person 33-556-333-333
Dr. Bernard Verbeeten Instituut *Recruiting*
Tilburg, , 5042 SB
Netherlands
Recruiting Contact Person 31-13-594-7777
Additional Information:
Study ID Numbers: CDR0000068532; EORTC-22997,EORTC-20971
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014326
Other Grade 1 Follicular Lymphoma Studies:
1. Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
2. Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
3. Oblimersen and Rituximab in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
4. Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
5. Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Related Studies:
Other grade 1 follicular lymphoma Clinical Trials
Other Clinical Trials
Other ENSCHEDE Clinical Trials
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
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