MDACC Study Summary 2006-0519 (Archived)

Study Summary
No. 2006-0519:.......Pain......Allen W. Burton......Anesthesiology

Study Summary Title



Study Summary Number:	2006-0519

Study Title:	The CAFE Study- Cancer Patient Fracture Evaluation- A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-Surgical Fracture Management in the Treatment of Painful, Vertebral Body Compression Fractures in Cancer Patients

Physician

New Patient Referral



Name:	Allen W. Burton	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Anesthesiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6070 Contact us about clinical trials

General Information



Disease Group:	Pain	Supported By:	N/A

Phase of Study:	Phase II/Phase III	Return Visit:	7 to 10 day clinic visit for BK group. Clinic visit for both treatment groups at: 1 month (+/- 1 week) 3 months (+/- 2 weeks) 6 months (+/- 1 month) 12 months (+/- 1 month)

Treatment Agents:	Balloon Kyphoplasty	Home Care:	NA

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	The protocol visits follow standard of care visits/procedures for each FDA approved treatment group. Length of stay varies with each patient; based on their individual clinical needs. Overnight hospital stay not required per protocol.


Description/ Intervention:	The goal of this clinical research study is to compare the safety and ability of balloon kyphoplasty with nonsurgical therapy in the treatment of VCFs. Researchers want to find out which treatment may be best for patients who have cancer and VCFs.

Study Objectives / Outcomes

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

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.

The following secondary endpoints will also be examined. Comparisons will be made follow-up visits.
Safety:

Rate of study treatment-related adverse events,

Change in neurological status.

Clinical:

Change in functional status as assessed with the Roland-Morris Disability Questionnaire and 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.

Study Status Information



Study Activation / Registration Date:	05/17/2007

IRB Review and Approval Date:	05/17/2007

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	200 total at all sites.

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 1 to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by MRI or a fracture imaged by plain radiographs using the method of Genant.

2) Pain NRS score equal to or greater then 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 equal to or greater then 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 (equal to or greater then 100mg prednisone or 20mg dexamethasone per day), 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). For women of child-bearing potential, this site will perform a pregnancy test before all radiology (x-ray/MRI) procedures.

14) Patients who may require allogeneic bone marrow transplantation during the course of the study.

Links

Registration Number: NCT00211237
Study Information on Clinical Trials Registry (clinicaltrials.gov)