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Hypofractionated Radiotherapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376322
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Mauricio F Silva, Santa Casa de Porto Alegre

Brief Summary:
Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients with complicated bone metastases and have a low potential for severe treatment-related toxicities. There is a clear need for hypofractionated schedules in the complicated bone metastases population, especially when considering the overarching aim of palliative radiotherapy and the clinical features of this patient population. As well, current research examining hypofractionated approaches in bone metastases patients with impending or pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly scarce.

Condition or disease Intervention/treatment Phase
Bone Metastases Radiation: Radiotherapy Phase 2

Detailed Description:
In response the the already commented on, the purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Hypofractionated Radiotherapy (16 Gy in 2 Fractions With an Interval of One Week) for the Palliation of Complicated Bone Metastases in Patients With Poor Performance Status
Study Start Date : July 2014
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Radiotherapy in bone metastases
The purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.
Radiation: Radiotherapy
Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status




Primary Outcome Measures :
  1. Overall pain response at the site of treatment, which will be measured at two months post-treatment. Pain response will be measured using the International Consensus on Palliative Radiotherapy Endpoints Pain Response Categories. [ Time Frame: 2 months after the end of the second radiotherapy fraction ]
    The general follow up will finish 1 year after each patient inclusion


Secondary Outcome Measures :
  1. Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22 [ Time Frame: General follow up will be 1 year after each patient inclusion ]
    Quality of life assessed by these 2 questionnaries will follow composite information

  2. Side effects of Radiotherapy. [ Time Frame: General follow up will be 1 year after each patient inclusion ]
    Nausea and vomiting, pain flare, skin rash, esophagitis, mucositis, diarrhea, spinal cord/cauda equina compression, pathologic fracture, re-irradiation rate).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically proven malignancy.
  2. Patients aged 18 and above.
  3. Advanced cancer patients with at least one complicated bone metastasis. A complicated bone metastasis will be operationally defined as a bone metastasis that has an accompanying: soft tissue mass or extraosseous component penetrating the normal cortical boundary; neuropathic pain; post surgical intervention for bone fixation; impending fracture or high fracture risk in weight bearing long bone as defined by Harrington's criteria but not surgical candidate: lytic bone lesion involving more than ½ the diameter of the bone cortex , greater than 2.5 cm in greatest diameter, or in the intertrochanteric line (29).
  4. Patients with Karnofsky Performance Status (KPS) 30-60 at the time of baseline evaluation.
  5. Patients who are planned to receive radiation treatment to the complicated site(s) being followed for study.
  6. Patients who had surgery for complicated bone metastases.
  7. Patients who are currently taking any systemic therapy (i.e. chemotherapy, hormone therapy, or bone modifying agents) or planning to begin systemic therapy within two weeks of treatment will be allowed to participate in the study; study personnel will note any use of systemic therapy in the study records.
  8. Patients who are able to provide a worst pain score at the complicated site(s) being followed for study.
  9. Patients who are able and willing to fill out a daily diary.
  10. Patients who are able to provide informed consent prior to being enrolled to the study.

Exclusion Criteria:

  1. Patients with leukemia or Hodgkin's/non-Hodgkin's lymphoma.
  2. Patients who are surgical candidates with pathologic fractures or lesions at high risk for pathologic fracture in the humerus, radius, ulna, femur, tibia, or fibula. They will be eligible for post-operative hypofractionated radiotherapy.
  3. Patients with spinal cord compression or cauda equina syndrome.
  4. Patients who are currently receiving any radiopharmaceuticals.
  5. Patients who are unable to record a pain score, complete a daily diary or to communicate requested information to study personnel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376322


Locations
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Brazil
ISCMPA
Porto Alegre, RS, Brazil, 90000
ICESP
São Paulo, SP, Brazil
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Italy
S. Maria Hospital
Terni, Italy
Sponsors and Collaborators
Santa Casa de Porto Alegre
Investigators
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Principal Investigator: Maurício F Silva, PhD Medical Doctor at Radiation Oncology Unit
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Responsible Party: Mauricio F Silva, Medical Doctor at Radiation Oncology Unity, Santa Casa de Porto Alegre
ClinicalTrials.gov Identifier: NCT02376322    
Other Study ID Numbers: ISCMPA01
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases