CAFE Study - Cancer Patient Fracture Evaluation

Completed · Not applicable

Conditions studied: Cancer, Spinal Fractures

In brief

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.

Key facts

Study ID

NCT00211237

Run by

Medtronic Spine LLC

People needed

134

Starts

2005-05-01

Expected to finish

2009-12-01

Last updated by the study team

2021-01-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant
• Pain NRS score ≥4 on a scale of 0 to 10
• When the patient is newly diagnosed with multiple myeloma, the pain assessment must not be done until after completion of at least one pulse of steroid therapy or one week after the initiation of active multiple myeloma therapy.
• Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24
• Patients must be at least 21 years old.
• No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment
• No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment
• No major surgery to the spine planned for at least 1 month following enrollment
• Life expectancy of ≥ 3 months
• Patient has sufficient mental capacity to comply with the protocol requirements
• Patient has stated availability for all study visits
• Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.

You may not qualify if…

• Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
• Concurrent Phase I investigational anti-cancer treatment
• Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
• VCF morphology deemed unsuitable for balloon kyphoplasty
• Additional non-kyphoplasty surgical treatment is required for the index fracture
• Patients requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
• Patients with a platelet count of < 20,000 measured at the time of hospital admission for the procedure
• Spinal cord compression or canal compromise requiring decompression
• Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled.
• Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
• Known allergy to bone cement or contrast medium used in the treatment of study subjects
• MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
• Positive baseline pregnancy test (for women of child-bearing potential)
• Patients who may require allogeneic bone marrow transplantation during the course of the study.
• Other Reasons for Lack of Enrollment:
• A. Patient is afraid to have surgery
• B. Patient is afraid to have anesthesia
• C. Patient/family is not willing to participate in research
• D. Patient is not willing to be randomized

Where it is running

• Valley Radiology Inc., UCSD — Escondido, California, United States
• Boulder Neurosurgical Associates — Boulder, Colorado, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Sibley Memorial Hospital — Chevy Chase, Maryland, United States
• Greater Oncology Associates — Silver Spring, Maryland, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• St. Vincent's Hospital — Fitzroy, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Institut Jules Bordet — Brussels, Belgium
• Foothills Hospital — Calgary, Alberta, Canada
• Toronto Western Hospital — Toronto, Ontario, Canada
• Montreal General Hospital — Montreal, Quebec, Canada
• Charité Virchow-Klinikum — Berlin, Germany
• Medizinische Hochschule — Hanover, Germany
• National Center for Spinal Disorders — Budapest, Hungary
• Akademiska Sjukhuset — Uppsala, Sweden
• Royal London — London, United Kingdom

Full record on ClinicalTrials.gov

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