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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. května 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

261

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Zoledronic acid
Zoledronic acid, vitamin D and calcium supplements.
Doplněk stravy: 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.
Doplněk stravy: 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.
Lék: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Ostatní jména:
  • Zometa
Experimentální: Zoledronic acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Doplněk stravy: 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.
Lék: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Ostatní jména:
  • Zometa
Lék: Sm-153
Single dose intravenously 1 mCi/kg body weight.
Ostatní jména:
  • Samarium-153
Záření: Sr-89
Single dose intravenously 4 mCi.
Ostatní jména:
  • Stroncium-89

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Development of a Malignant Skeletal-related Events (SRE)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Radiation Therapy Oncology Group

Spolupracovníci

National Cancer Institute (NCI)
NRG Oncology

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

11. července 2006

Primární dokončení (Aktuální)

1. ledna 2012

Dokončení studie (Aktuální)

27. února 2017

Termíny zápisu do studia

První předloženo

16. srpna 2006

První předloženo, které splnilo kritéria kontroly kvality

16. srpna 2006

První zveřejněno (Odhad)

17. srpna 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. června 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. května 2019

Naposledy ověřeno

1. května 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Zdravotní podmínky

Drogové intervence

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
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