CAFE Study - Cancer Patient Fracture Evaluation

NCT00211237 | Completed Results DMC

• 1 other identifier: SP0401 - CAFE Study
• Study Type: interventional
• Target: 134
• Locations: 8 countries
• Sites: 20

Brief Summary

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.

Conditions

Cancer; Spinal Fractures

Keywords

Balloon Kyphoplasty; Cancer; Vertebral Compression Fracture; Back Pain; Spine

Outcome Measures

Primary Outcomes (1)

• The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month

  The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)

  Baseline and 1 Month

Secondary Outcomes (33)

• Change in Roland-Morris Disability Questionnaire Score

  Baseline, 1 month, 3 months, 6 months, and 12 months

• Change in Functional Status Assessed With the Karnofsky Performance Scale

  Baseline and 1 month

• Change in Functional Status Assessed With the Karnofsky Performance Scale

  Baseline, 1 month, 3 months, 6 months, and 12 months

• Change in Back Pain

  Baseline and 1 month

• Change in Back Pain

  Baseline, 1 month, 3 months, 6 months, and 12 months

Study Arms (2)

Balloon Kyphoplasty (BKP)

EXPERIMENTAL

The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.

Device: Balloon Kyphoplasty

Non Surgical Management

ACTIVE COMPARATOR

The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.

Other: Non Surgical Management

Interventions

Balloon Kyphoplasty DEVICE

Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.

Also known as: KyphX Inflatable Bone Tamps

Balloon Kyphoplasty (BKP)

Non Surgical Management OTHER

Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.

Non Surgical Management

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Medtronic Spine LLC: lead

Study Sites (20)

Valley Radiology Inc., UCSD

Escondido, California, 92025, United States

Location

Boulder Neurosurgical Associates

Boulder, Colorado, 80304, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Sibley Memorial Hospital

Chevy Chase, Maryland, 20815, United States

Location

Greater Oncology Associates

Silver Spring, Maryland, 20910, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Institut Jules Bordet

Brussels, Belgium

Location

Foothills Hospital

Calgary, Alberta, T2N2T9, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Charité Virchow-Klinikum

Berlin, Germany

Location

Medizinische Hochschule

Hanover, Germany

Location

National Center for Spinal Disorders

Budapest, Hungary

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Royal London

London, United Kingdom

Location

Related Publications (1)

• Berenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman JB, Bastian L, Ashraf T, Vrionis F; Cancer Patient Fracture Evaluation (CAFE) Investigators. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):225-35. doi: 10.1016/S1470-2045(11)70008-0. Epub 2011 Feb 16.

  PMID: 21333599 DERIVED

MeSH Terms

Conditions

Neoplasms; Spinal Fractures; Back Pain

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spine and Biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Study Officials

• James Berenson, M.D.

  Institute for Myeloma & Bone Cancer Research

  PRINCIPAL INVESTIGATOR

• Frank Vrionis, M.D.

  H. Lee Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 5, 2021
• Results First Posted: May 14, 2010

Record last verified: 2017-06

Locations

GB (1); HU (1); SE (1); AU (2); DE (2); CA (3); US (9); BE (1)