|
Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases Clinical research trials and Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases. Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases clinical trial. Participants typically obtain the most effective healthcare available for their Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases  Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases
Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases
For Condition: bone metastases,Pain
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) radiation therapy is more effective than multiple-fraction reirradiation (many small doses of radiation therapy) in relieving bone pain caused by bone metastases. PURPOSE: Randomizedphase III trial to compare the effectiveness of single-dose radiation therapy with that of multiple-dose radiation therapy in treating patients who have painful bone metastases.
Details: OBJECTIVES: Primary - Compare pain relief in patients undergoing single fraction vs multiple fraction re-irradiation of painful bone metastases. Secondary - Compare overall pain relief in patients treated with these regimens. - Compare time to pain progression in patients treated with these regimens. - Correlate initial irradiation response with pain relief after re-irradiation in these patients. - Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens. - Compare quality of life in patients treated with these regimens (patients in Canada and the Netherlands only). - Compare characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens. - Compare the incidence of acute severe radiation-related side effects in patients treated with these regimens. - Compare the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to initial radiotherapy (yes vs no), initial fractionation (single fraction vs multiple fraction), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive single fraction radiotherapy on day 1. - Arm II: Patients receive multiple fraction radiotherapy once daily on days 1-5 or on days 1-8 if re-irradiation of the spine and/or whole pelvis is involved. At least 4 weeks after the first re-treatment, patients in both arms may receive a second re-treatment in the absence of unacceptable pain progression or unacceptable toxicity. Patients complete a Brief Pain Inventory questionnaire on days 7 and 14, monthly during months 1-6, and at months 9 and 12. Quality of life is assessed at baseline and then monthly during months 1-6. Patients are followed for up to 1 year. PROJECTED ACCRUAL: A total of 650 patients (325 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignancy - Diagnosis by needle biopsy, bone marrow biopsy, cytology, or surgical biopsy or resection - Bone metastases at clinically painful areas confirmed by any of the following: - Plain radiographs - Radionuclide bone scans - CT scans - Magnetic resonance imaging - Worst pain score of 2/10 using the Brief Pain Inventory - Pain arising from previously irradiated metastases and not from progressive disease in adjoining or remote areas - Initial radiotherapy field is reproducible for re-irradiation - Current site of pain for palliative radiotherapy must be smaller or similar in size to initial treatment field - No clinical or radiological evidence of pathological fractures in extremities of the area to be re-irradiated - No high-risk lytic lesion > 3 cm OR > 50% cortical erosion of bone diameter - No clinical or radiological evidence of spinal cord compression - Ineligible for surgical intervention PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 50-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Fertile patients must use effective barrier contraception - Able and willing to complete quality of life questionnaire in English, French, or Dutch - Must be accessible for treatment follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 30 days since prior strontium chloride Sr 89 - More than 30 days since prior half-body radiotherapy, including the current re-irradiation field - At least 4 weeks since prior initial radiotherapy Surgery - No prior palliative surgery in treatment area - No concurrent surgical intervention on treatment area Other - No plan to make an immediate change in analgesic regimen
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardChow, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Peter Hoskin 44-019-2384-4533
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting William McMillan 905-387-9495
Kennemer Gasthuis - Locatie EG *Recruiting*
Haarlem, , 2000
Netherlands
Recruiting P.W.G. der Linden 31-23-552-5252
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Conrad Falkson 807-684-7200
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Jackson Wu 403-944-2095
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Abdenour Nabid 819-346-1110 ext. 14602
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Susan MacDonald 709-777-8091
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Edward Chow 416-480-4998
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Abdul Dar 519-685-8650
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Andrea Bezjak 416-946-2132
Additional Information:
Study ID Numbers: CDR0000357423; CAN-NCIC-SC.20
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080912
Other Pain Studies:
1. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
2. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
3. Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
4. Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
5. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
Related Studies:
Other Pain Clinical Trials
Other Alberta Clinical Trials
Other Calgary Clinical Trials
Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases
|
|
|
|
|
|
|
|
