Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Supportive Care Trial Results 2 Provides links to clinical trial results about supportive care (care given to improve a patient's quality of life). Highlights from ASCO 2003 3 A collection of links to material summarizing some of the important clinical trial results announced at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO). Coping with Cancer 4 Managing side effects and complications caused by cancer and its treatment.

Key Words

Spinal cord compression, radiation therapy, lung cancer, prostate cancer, breast cancer, incontinence. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ⁵.)

Summary

Surgery followed by radiation is more effective than radiation alone in treating certain patients suffering from spinal cord compression caused by metastatic cancer (cancer that has spread). The addition of surgery allows many of these patients to retain the ability to walk and to control their bladder for a longer period of time.

Source

The Lancet, August 20, 2005 (see the journal abstract).

Background

Spinal cord compression occurs in 10 to 20 percent of all cancer patients, especially lung, prostate and breast cancer patients. When a tumor spreads to the vertebrae, the spinal cord can be compressed and can cause some patients to lose mobility or bladder control. Researchers wondered whether surgery to remove the tumor in addition to radiation would benefit cancer patients by alleviating the pressure and stabilizing the spine.

The Study

In this randomized phase III study, researchers compared the efficacy of surgery combined with radiation as opposed to radiation alone in relieving cancer-related spinal cord compression. The primary endpoint of the study was the ability to walk after treatment. "Walking" was defined as taking at least two steps with each foot unassisted by another person (a cane or walker could be used). A secondary endpoint was the ability to retain bladder control (continence).

Patients were enrolled over a 10-year period, between September 1992 and December 2002. Of the 101 patients who participated, 32 started the trial unable to walk. Only patients with solid tumors compressing a single area of the spinal cord were admitted to the study.

As much tumor as possible was removed from the spinal columns of 50 patients, who were then treated with radiation. Fifty-one patients received radiation only. Patients had been randomly assigned to one of the two treatment groups.

The study, led by Roy A. Patchell, M.D., of the University of Kentucky Medical Center in Lexington, was halted early due to the overwhelming benefits of surgery combined with radiation. The results were originally presented at the 2003 annual meeting of the American Society of Clinical Oncology.

Results

Patients who received surgery in addition to radiation for their spinal compression were able to walk significantly longer after this treatment: a median of 122 days, compared to a median of 13 days for patients receiving radiation only. Surgically treated patients also maintained continence significantly longer: a median of 156 days compared to 17 days for the radiation-only group.

Sixteen patients in each group entered the study unable to walk. Ten patients treated with surgery and radiation regained the ability to walk (62 percent), compared to only three receiving radiation alone (19 percent).

Surgically treated patients survived a median of 126 days as opposed to 100 days for the radiation-only group, and also didn't need as much morphine and steriods to ease pain. Those treated with surgery stayed in the hospital no longer than those receiving radiation-only.

All of these findings were statistically significant.

Comments

“This was a wildly positive trial,” said Patchell. “We were able to show it works best as an initial treatment…followed by radiation.”

Writing in an accompanying editorial, Martin J. van den Bent, M.D., of the Daniel den Hoed Oncology Center in Rotterdam, the Netherlands, agreed. This study, he wrote, "seems to pave the way for a widespread acceptance of decompressive spinal column surgery in selected patients."

Limitations

The trial limited participation to patients with a single area of metastatic epidural spinal cord compression and also an expected survival of three months, noted van den Bent. "It will be...a great clinical challenge to select patients for this type of intervention and to identify those patients in whom the improved outcome outweighs the efforts and costs of surgical intervention."

Glossary Terms

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.

Inability to control the flow of urine from the bladder (urinary incontinence) or the escape of stool from the rectum (fecal incontinence).

A statistics term. The middle value in a set of measurements.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.