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Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer

31 mei 2019 bijgewerkt door: Radiation Therapy Oncology Group

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

OBJECTIVES:

Primary

  • Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or delaying the time to development of malignant skeletal-related events (SREs) (defined as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone) in patients with bone metastases secondary to prostate, lung, or breast cancer.

Secondary

  • Compare the rate of SREs at 1 year in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare the effect of these regimens on pain control in these patients.
  • Evaluate resource utilization and cost effectiveness of these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to primary disease site (prostate vs breast vs lung) and number of bone metastases (≤ 2 vs > 2). Patients are randomized to 1 of 2 treatment arms.

Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from start of protocol treatment.

After completion of study treatment, patients are followed every 6 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

261

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Mobile, Alabama, Verenigde Staten, 36608
        • Providence Cancer Center at Providence Hospital
    • California
      • Burbank, California, Verenigde Staten, 91505
        • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
      • Carmichael, California, Verenigde Staten, 95608
        • Mercy Cancer Center at Mercy San Juan Medical Center
      • Los Angeles, California, Verenigde Staten, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Pomona, California, Verenigde Staten, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Roseville, California, Verenigde Staten, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Verenigde Staten, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • Travis Air Force Base, California, Verenigde Staten, 94535-1800
        • General Robert Huyser Cancer Center at David Grant Medical Center
    • Florida
      • Fort Lauderdale, Florida, Verenigde Staten, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Jacksonville, Florida, Verenigde Staten, 32207
        • Baptist Cancer Institute - Jacksonville
      • Jacksonville, Florida, Verenigde Staten, 32207
        • Integrated Community Oncology Network at Southside Cancer Center
      • Jacksonville, Florida, Verenigde Staten, 32258
        • Baptist Medical Center South
      • Jacksonville Beach, Florida, Verenigde Staten, 32250
        • Integrated Community Oncology Network
      • Miami, Florida, Verenigde Staten, 33133
        • Miami Cancer Center at Mercy Hospital
      • Miami Beach, Florida, Verenigde Staten, 33140
        • CCOP - Mount Sinai Medical Center
      • Orange Park, Florida, Verenigde Staten, 32073
        • Integrated Community Oncology Network - Orange Park
      • Palatka, Florida, Verenigde Staten, 32177
        • Florida Cancer Center - Palatka
      • Panama City, Florida, Verenigde Staten, 32401
        • Bay Medical
      • Saint Augustine, Florida, Verenigde Staten, 32086
        • Flagler Cancer Center
      • Tampa, Florida, Verenigde Staten, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Columbus, Georgia, Verenigde Staten, 31904
        • John B. Amos Cancer Center
      • Gainesville, Georgia, Verenigde Staten, 30501
        • Northeast Georgia Medical Center
    • Illinois
      • Arlington Heights, Illinois, Verenigde Staten, 60005
        • Northwest Community Hospital
      • Downers Grove, Illinois, Verenigde Staten, 60515-1500
        • Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
      • Harvey, Illinois, Verenigde Staten, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Hines, Illinois, Verenigde Staten, 60141
        • Veterans Affairs Medical Center - Hines
      • Oak Lawn, Illinois, Verenigde Staten, 60453-2699
        • Advocate Christ Medical Center
      • Park Ridge, Illinois, Verenigde Staten, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Peoria, Illinois, Verenigde Staten, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Springfield, Illinois, Verenigde Staten, 62702
        • Cancer Institute at St. John's Hospital
      • Urbana, Illinois, Verenigde Staten, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Goshen, Indiana, Verenigde Staten, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Muncie, Indiana, Verenigde Staten, 47303-3499
        • Cancer Center at Ball Memorial Hospital
      • South Bend, Indiana, Verenigde Staten, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Ames, Iowa, Verenigde Staten, 50010
        • McFarland Clinic, PC
      • Des Moines, Iowa, Verenigde Staten, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Verenigde Staten, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Sioux City, Iowa, Verenigde Staten, 51101
        • Siouxland Hematology-Oncology Associates, LLP
    • Kansas
      • Lawrence, Kansas, Verenigde Staten, 66044
        • Lawrence Memorial Hospital
      • Wichita, Kansas, Verenigde Staten, 67214
        • CCOP - Wichita
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40503-9985
        • Central Baptist Hospital
    • Louisiana
      • Alexandria, Louisiana, Verenigde Staten, 71315-3198
        • Tulane Cancer Center Office of Clinical Research
    • Maine
      • Lewiston, Maine, Verenigde Staten, 04240
        • Central Maine Comprehensive Cancer Center at Central Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21229
        • St. Agnes Hospital Cancer Center
    • Massachusetts
      • Fall River, Massachusetts, Verenigde Staten, 02721
        • Hudner Oncology Center at Saint Anne's Hospital - Fall River
      • Hyannis, Massachusetts, Verenigde Staten, 02601
        • Cape Cod Hospital
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Dearborn, Michigan, Verenigde Staten, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Detroit, Michigan, Verenigde Staten, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Flint, Michigan, Verenigde Staten, 48503
        • Hurley Medical Center
      • Flint, Michigan, Verenigde Staten, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Verenigde Staten, 49801
        • Dickinson County Healthcare System
      • Kalamazoo, Michigan, Verenigde Staten, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Verenigde Staten, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, Verenigde Staten, 48912-1811
        • Sparrow Regional Cancer Center
      • Warren, Michigan, Verenigde Staten, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Saint Cloud, Minnesota, Verenigde Staten, 56303
        • CentraCare Clinic - River Campus
    • Mississippi
      • Pascagoula, Mississippi, Verenigde Staten, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64131
        • CCOP - Kansas City
      • Kansas City, Missouri, Verenigde Staten, 64108
        • Truman Medical Center - Hospital Hill
      • Springfield, Missouri, Verenigde Staten, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Verenigde Staten, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Verenigde Staten, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Verenigde Staten, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Verenigde Staten, 59107-7000
        • Billings Clinic - Downtown
      • Great Falls, Montana, Verenigde Staten, 59405
        • Great Falls Clinic - Main Facility
    • Nebraska
      • Kearney, Nebraska, Verenigde Staten, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New Jersey
      • Jamesburg, New Jersey, Verenigde Staten, 08831
        • Princeton Radiation Oncology Center
      • Marlton, New Jersey, Verenigde Staten, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Princeton, New Jersey, Verenigde Staten, 08540-3298
        • University Medical Center at Princeton
      • Vineland, New Jersey, Verenigde Staten, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
      • Voorhees, New Jersey, Verenigde Staten, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87109
        • New Mexico Cancer Center
    • New York
      • Brooklyn, New York, Verenigde Staten, 11215
        • New York Methodist Hospital
      • Canandaigua, New York, Verenigde Staten, 14424
        • Sands Cancer Center
      • Plattsburgh, New York, Verenigde Staten, 12901
        • Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
      • Rochester, New York, Verenigde Staten, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, Verenigde Staten, 14620
        • Highland Hospital of Rochester
      • Rochester, New York, Verenigde Staten, 14621
        • Lipson Cancer and Blood Center at Rochester General Hospital
      • Rochester, New York, Verenigde Staten, 14626
        • University Radiation Oncology at Parkridge Hospital
    • North Carolina
      • Asheville, North Carolina, Verenigde Staten, 28801
        • Mission Hospitals - Memorial Campus
      • Charlotte, North Carolina, Verenigde Staten, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Goldsboro, North Carolina, Verenigde Staten, 27534
        • Wayne Radiation Oncology
    • North Dakota
      • Minot, North Dakota, Verenigde Staten, 58701
        • Trinity Cancercare Center
    • Ohio
      • Akron, Ohio, Verenigde Staten, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Verenigde Staten, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Alliance, Ohio, Verenigde Staten, 44601
        • Radiation Oncology Center
      • Barberton, Ohio, Verenigde Staten, 44203
        • Barberton Citizens Hospital
      • Canton, Ohio, Verenigde Staten, 44708
        • Mercy Cancer Center at Mercy Medical Center
      • Chillicothe, Ohio, Verenigde Staten, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Verenigde Staten, 43215
        • CCOP - Columbus
      • Dayton, Ohio, Verenigde Staten, 45405
        • Grandview Hospital
      • Dayton, Ohio, Verenigde Staten, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Verenigde Staten, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Verenigde Staten, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Verenigde Staten, 45420
        • CCOP - Dayton
      • Franklin, Ohio, Verenigde Staten, 45005-1066
        • Middletown Regional Hospital
      • Kettering, Ohio, Verenigde Staten, 45429
        • Charles F. Kettering Memorial Hospital
      • Mansfield, Ohio, Verenigde Staten, 44903
        • MedCentral - Mansfield Hospital
      • Salem, Ohio, Verenigde Staten, 44460
        • Cancer Care Center, Incorporated
      • Troy, Ohio, Verenigde Staten, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wooster, Ohio, Verenigde Staten, 44691
        • Cancer Treatment Center
      • Wright-Patterson Air Force Base, Ohio, Verenigde Staten, 45433-5529
        • United States Air Force Medical Center - Wright-Patterson
      • Xenia, Ohio, Verenigde Staten, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Abington, Pennsylvania, Verenigde Staten, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Beaver, Pennsylvania, Verenigde Staten, 15009
        • UPMC Cancer Center at Beaver Medical Center
      • Clairton, Pennsylvania, Verenigde Staten, 15025
        • UPMC Cancer Center at Jefferson Regional Medical Center
      • Dunmore, Pennsylvania, Verenigde Staten, 18512
        • Northeast Radiation Oncology Center
      • Greensburg, Pennsylvania, Verenigde Staten, 15601
        • UPMC Cancer Center - Arnold Palmer Pavilion
      • Johnstown, Pennsylvania, Verenigde Staten, 15901
        • UPMC Cancer Center at the John P. Murtha Pavilion
      • McKeesport, Pennsylvania, Verenigde Staten, 15132
        • UPMC Cancer Center at UPMC McKeesport
      • Moon, Pennsylvania, Verenigde Staten, 15108
        • UPMC - Moon
      • Natrona Heights, Pennsylvania, Verenigde Staten, 15065
        • UPMC Cancer Center - Natrona Heights
      • New Castle, Pennsylvania, Verenigde Staten, 16105
        • Jameson Memorial Hospital - North Campus
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • UPMC Cancer Center at UPMC Presbyterian
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213-2582
        • UPMC - Shadyside
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • UPMC Cancer Center at Magee-Womens Hospital
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15215
        • UPMC Cancer Center at UPMC St. Margaret
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15237
        • UPMC Cancer Center at UPMC Passavant
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15243
        • UPMC Cancer Center - Upper St. Clair
      • Seneca, Pennsylvania, Verenigde Staten, 16346
        • UPMC Cancer Center at UPMC Northwest
      • State College, Pennsylvania, Verenigde Staten, 16803
        • Mount Nittany Medical Center
      • Uniontown, Pennsylvania, Verenigde Staten, 15401
        • UPMC Cancer Center - Uniontown
      • Washington, Pennsylvania, Verenigde Staten, 15301
        • Washington Hospital Cancer Center
      • York, Pennsylvania, Verenigde Staten, 17405
        • York Cancer Center at Apple Hill Medical Center
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Greenville, South Carolina, Verenigde Staten, 29615
        • CCOP - Greenville
    • Utah
      • Murray, Utah, Verenigde Staten, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Saint George, Utah, Verenigde Staten, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Verenigde Staten, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Verenigde Staten, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Washington
      • Federal Way, Washington, Verenigde Staten, 98003
        • St. Francis Hospital
      • Puyallup, Washington, Verenigde Staten, 98372
        • Good Samaritan Cancer Center
      • Seattle, Washington, Verenigde Staten, 98101
        • CCOP - Virginia Mason Research Center
      • Tacoma, Washington, Verenigde Staten, 98405-3004
        • Franciscan Cancer Center at St. Joseph Medical Center
      • Tacoma, Washington, Verenigde Staten, 98405
        • CCOP - Northwest
      • Tacoma, Washington, Verenigde Staten, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Yakima, Washington, Verenigde Staten, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Appleton, Wisconsin, Verenigde Staten, 54911
        • Theda Care Cancer Institute
      • Green Bay, Wisconsin, Verenigde Staten, 54301
        • Bellin Memorial Hospital
      • Wisconsin Rapids, Wisconsin, Verenigde Staten, 54494
        • Riverview UW Cancer Center at Riverview Hospital
    • Wyoming
      • Sheridan, Wyoming, Verenigde Staten, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Histologically or cytologically proven diagnosis of solid tumor malignancy of lung, breast, or prostate prior to registration;

  2. Appropriate diagnosis for protocol entry, based upon the following minimum diagnostic workup:

    2.1 History/physical examination within 8 weeks prior to registration; 2.2 Bone scan within 4 weeks prior to registration; bone metastases must be visible on the scan. Other scanning modalities, such as magnetic resonance imaging (MRI), positron emission tomography (PET) 2.3 Dental evaluation according to the dental exam checklist (carried out by the investigator, the investigator's designee, or by a qualified dental professional [dental hygienist or dentist]), including history of dental surgery (e.g., extraction or implant) within 8 weeks prior to registration and recorded on the dental exam checklist; Note: If the patient has received prior oral bisphosphonate therapy and has had a prior dental evaluation within 8 weeks of registration, the evaluation should not be repeated.

    2.4 Complete blood count (CBC)/differential within 2 weeks prior to registration, with adequate bone marrow function defined as follows:

    • White blood cell count (WBC) ≥ 2400 cells/mm^3;
    • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
    • Platelets ≥ 60,000 cells/mm3;
    • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve the required hemoglobin is permitted).

    2.5 Serum creatinine < 3 mg/dL (265 μmol/L) within 2 weeks prior to registration; 2.6 Total bilirubin < 2.5 mg/dL (43 μmol/L) within 2 weeks prior to registration; 2.7 Pregnancy test (urine dipstick or serum) for women of childbearing potential within 2 weeks prior to registration;

  3. ≥ 18 years of age;
  4. Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries;
  5. Patients receiving systemic chemotherapy or hormonal therapy are eligible for this study. See Sections 6.0 and 7.0 for further details. Note: All patients must complete external beam radiation therapy ≥ 14 days prior to registration. If patients have undergone CyberKnife treatment, treatment must be completed ≥ 14 days prior to registration.
  6. Patients may have received prior oral bisphosphonate therapy, such as Fosamax® or similar medications. Duration of bisphosphonate treatment prior to study entry must be documented, and all bisphosphonates other than the study drug must be discontinued prior to registration.
  7. Women of childbearing potential and male participants must agree to practice an adequate means of birth control throughout their participation in the study.
  8. Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria

  1. Patients with brain metastases and/or spinal cord compression are excluded. Note: Patients with no evidence of disease in the brain after treatment for brain metastases are eligible.
  2. Patients with painful bone metastases are not permitted until these bone metastases are successfully treated (for example by external beam irradiation) prior to registration, and the patient has stable pain for at least 2 weeks after that treatment (Stable pain is defined for this study as a patient response of 1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI).
  3. Prior treatment with Strontium-89 or Samarium-153 for bone metastases.
  4. Treatment for more than 6 months with IV bisphosphonates prior to study entry;
  5. Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to registration

  6. Severe, active co-morbidity, defined as follows:

    6.1 Evidence in the six months prior to study entry of uncontrolled congestive heart failure, hypertension refractory to treatment, or symptomatic coronary artery disease; 6.2 Current, active dental problems within 4 weeks of registration, including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; current or prior diagnosis of osteonecrosis of the jaw (ONJ); exposed bone in the mouth; or slow healing after dental procedures; 6.3 Dental surgery (e.g., extractions, implants) within 6 weeks of study entry and while receiving study treatment; for patients who require dental surgery, there are no data to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw (ONJ) [see Section 7.2.4].

    6.4 Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

  7. Pregnant or lactating patients are excluded, as treatment may be harmful to embryos and/or nursing infants.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Zoledronic acid
Zoledronic acid, vitamin D and calcium supplements.
Voedingssupplement: Calcium
At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
Voedingssupplement: Vitamin D
400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
Geneesmiddel: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Andere namen:
  • Zometa
Experimenteel: Zoledronic acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Voedingssupplement: Calcium
At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
Geneesmiddel: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Andere namen:
  • Zometa
Geneesmiddel: Sm-153
Single dose intravenously 1 mCi/kg body weight.
Andere namen:
  • Samarium-153
Straling: Sr-89
Single dose intravenously 4 mCi.
Andere namen:
  • Strontium-89

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Development of a Malignant Skeletal-related Events (SRE)
Tijdsspanne: From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.
Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.
From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year
Tijdsspanne: From randomization to 1 year
Skeletal-related events are defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.
From randomization to 1 year
Overall Survival
Tijdsspanne: From randomization to last follow-up. Maximum follow-up at time of analysis was 101.7 months.
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
From randomization to last follow-up. Maximum follow-up at time of analysis was 101.7 months.
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year
Tijdsspanne: Baseline and 1 year
The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change score at one year is calculated as one year score - baseline score with a positive change score indicating improvement in QOL.
Baseline and 1 year
Change in Brief Pain Inventory (BPI) at One Year
Tijdsspanne: Baseline and 1 year
The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain. The BPI assesses severity (pain at its "worst," "least," "average," and "now"), and interference (how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Patients rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function on a scale of 0 to 10, with 0=no pain/interference and 10=interferes completely/worst pain imaginable.
Baseline and 1 year
Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year
Tijdsspanne: Baseline and 1 year
The EQ-5D-3L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Change at one year is calculated as one-year score - baseline score with positive change indicating improved quality of life.
Baseline and 1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Radiation Therapy Oncology Group

Medewerkers

National Cancer Institute (NCI)
NRG Oncology

Onderzoekers

  • Studie stoel: Michael J. Seider, MD, PhD, FACR, Summa Center for Cancer Care at Akron City Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 juli 2006

Primaire voltooiing (Werkelijk)

1 januari 2012

Studie voltooiing (Werkelijk)

27 februari 2017

Studieregistratiedata

Eerst ingediend

16 augustus 2006

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2006

Eerst geplaatst (Schatting)

17 augustus 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

31 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RTOG 0517
  • CDR0000491233
  • NCI-2009-00727 (Register-ID: CTRP (Clinical Trial Reporting Program))

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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