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Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma Clinical research trials and Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma. Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma  Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
For Condition: stage 3 grade 1 follicular lymphoma,stage 4 grade 1 follicular lymphoma,stage 4 grade 2 follicular lymphoma,stage 3 grade 3 follicular lymphoma,stage 4 grade 3 follicular lymphoma,stage 3 grade 2 follicular lymphoma
Status: No longer recruiting
Sponsor(s): Commissie Voor Klinisch Toegepast Onderzoek , EORTC Lymphoma Cooperative Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated.
Details: OBJECTIVES: - Compare the effect of chlorambucil vs involved-field radiotherapy on progression-free survival of patients with previously untreated stage III or IV follicular lymphoma. - Compare the complete and partial remission rates and overall survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral chlorambucil on days 1-5. Treatment repeats every 4 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo radiotherapy on days 1 and 3 (and days 15 and 17 for split course). Quality of life is assessed at baseline, prior to course 3, 6, and 8 (arm I), and then at 4-6 weeks after study. Patients are followed at 4-6 weeks, 3-4 months (arm I), 3 months and 6 months (arm II), 11, 12, 15, 18, and 21 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 444 patients (222 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of follicular lymphoma - Stage III or IV disease - Grades I, II, or III - Previously untreated disease - Nodal and extranodal sites - Bidimensionally measurable disease by physical examination or diagnostic imaging - No CNS or orbital non-Hodgkin's lymphoma localization PATIENT CHARACTERISTICS: Age: - 18 and over (for patients at EORTC centers) - 65 and over (for patients at HOVON centers) Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 6.0 g/dL Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No severe cardiac disease that would preclude study treatment Pulmonary: - No severe pulmonary disease that would preclude study treatment Other: - HIV negative - No severe neurologic, psychiatric, or metabolic disease that would preclude study treatment - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No concurrent systemic corticosteroids, including dexamethasone for nausea and vomiting palliation (inhalation and topical corticosteroids allowed) Radiotherapy: - No concurrent elective radiotherapy to an adjacent negative lymph node Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RickM. Haas, , Antoni van Leeuwenhoek Hospital
Radiotherapeutisch Instituut Limburg-Maastricht
Maastricht, , NL-6229 ET
Netherlands
Institut Gustave Roussy
Villejuif, , F-94805
France
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Akademisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, , 3075 EA
Netherlands
Medisch Spectrum Twente
ENSCHEDE, , 7500 KA
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , 1081HV
Netherlands
Antoni van Leeuwenhoek Hospital
Amsterdam, , 1066 CX
Netherlands
Leiden University Medical Center
Leiden, , 2300 RC
Netherlands
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Maastro Clinic
HEERLEN, , NL-6401 PC
Netherlands
Additional Information:
Study ID Numbers: CDR0000069120; CKVO-2001-01,EORTC-20013,HOVON-CKTO-2001-01,EU-20131,HOVON-47NHL
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028691
Other Stage 3 Grade 2 Follicular Lymphoma Studies:
1. Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
2. Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
3. Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
Related Studies:
Other stage 3 grade 2 follicular lymphoma Clinical Trials
Other Clinical Trials
Other Amsterdam Clinical Trials
Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
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