CAFE Study - Cancer Patient Fracture Evaluation

NCT ID: NCT00211237

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-12-31

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.

Detailed Description

1. STUDY OBJECTIVES AND ENDPOINTS

1.1. Objectives

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

1.2. Primary Endpoint

The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.

1.3. Secondary Endpoints

The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.

Safety:

• Rate of study treatment-related adverse events
• Change in neurological status

Clinical:

• Change in functional status as assessed with Karnofsky Performance Scale
• Change in quality of life as assessed by the SF-36v2™ Health Survey
• Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)
• Change in back-pain analgesics used
• Change in ambulation status
• Changes in activities of daily living
• Time to treatment failure

Radiographic:

• Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
• Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab

In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.

Conditions

Cancer; Spinal Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Balloon Kyphoplasty (BKP)

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

Group Type: EXPERIMENTAL

Balloon Kyphoplasty

Intervention Type: 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.

Non Surgical Management

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.

Group Type: ACTIVE_COMPARATOR

Non Surgical Management

Intervention Type: 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.

Interventions

Balloon Kyphoplasty

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.

Intervention Type: DEVICE

Non Surgical Management

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

Intervention Type: OTHER

Other Intervention Names

KyphX Inflatable Bone Tamps

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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.

3. Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24

4. Patients must be at least 21 years old.

5. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment

6. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment

7. No major surgery to the spine planned for at least 1 month following enrollment

8. Life expectancy of ≥ 3 months

9. Patient has sufficient mental capacity to comply with the protocol requirements

10. Patient has stated availability for all study visits

11. Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.

Exclusion Criteria

1. 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.

2. Concurrent Phase I investigational anti-cancer treatment

3. Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function

4. VCF morphology deemed unsuitable for balloon kyphoplasty

5. Additional non-kyphoplasty surgical treatment is required for the index fracture

6. 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.

7. Patients with a platelet count of < 20,000 measured at the time of hospital admission for the procedure

8. Spinal cord compression or canal compromise requiring decompression

9. Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled.

10. Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)

11. Known allergy to bone cement or contrast medium used in the treatment of study subjects

12. MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)

13. Positive baseline pregnancy test (for women of child-bearing potential)

14. 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spine LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Berenson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute for Myeloma & Bone Cancer Research

Frank Vrionis, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center

Locations

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

Countries

United States; Australia; Belgium; Canada; Germany; Hungary; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 21333599 (View on PubMed)

Other Identifiers

SP0401 - CAFE Study

Identifier Type: -

Identifier Source: org_study_id