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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 maj 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

261

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Zoledronic acid
Zoledronic acid, vitamin D and calcium supplements.
Kosttillskott: 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.
Kosttillskott: 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.
Läkemedel: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Andra namn:
  • Zometa
Experimentell: Zoledronic acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Kosttillskott: 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.
Läkemedel: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Andra namn:
  • Zometa
Läkemedel: Sm-153
Single dose intravenously 1 mCi/kg body weight.
Andra namn:
  • Samarium-153
Strålning: Sr-89
Single dose intravenously 4 mCi.
Andra namn:
  • Strontium-89

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Development of a Malignant Skeletal-related Events (SRE)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Radiation Therapy Oncology Group

Samarbetspartners

National Cancer Institute (NCI)
NRG Oncology

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 juli 2006

Primärt slutförande (Faktisk)

1 januari 2012

Avslutad studie (Faktisk)

27 februari 2017

Studieregistreringsdatum

Först inskickad

16 augusti 2006

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2006

Första postat (Uppskatta)

17 augusti 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 maj 2019

Senast verifierad

1 maj 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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