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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

perjantai 31. toukokuuta 2019 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

261

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Tukevaa hoitoa
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Zoledronic acid
Zoledronic acid, vitamin D and calcium supplements.
Ravintolisä: 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.
Ravintolisä: 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.
Lääke: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Muut nimet:
  • Zometa
Kokeellinen: Zoledronic acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Ravintolisä: 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.
Lääke: zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Muut nimet:
  • Zometa
Lääke: Sm-153
Single dose intravenously 1 mCi/kg body weight.
Muut nimet:
  • Samarium-153
Säteily: Sr-89
Single dose intravenously 4 mCi.
Muut nimet:
  • Strontium-89

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time to Development of a Malignant Skeletal-related Events (SRE)
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Radiation Therapy Oncology Group

Yhteistyökumppanit

National Cancer Institute (NCI)
NRG Oncology

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 11. heinäkuuta 2006

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. tammikuuta 2012

Opintojen valmistuminen (Todellinen)

Maanantai 27. helmikuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 16. elokuuta 2006

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 16. elokuuta 2006

Ensimmäinen Lähetetty (Arvio)

Torstai 17. elokuuta 2006

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 14. kesäkuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 31. toukokuuta 2019

Viimeksi vahvistettu

Keskiviikko 1. toukokuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Kipu

Kliiniset tutkimukset Calcium

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Netherlands

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

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