CompletedNot Applicable

A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy

United States41 participantsStarted 2012-06-18

Plain-language summary

The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine. Researchers also want to learn how internal organs might move during radiation treatment. The goal of the second part of this study is to learn if it is safe to allow slightly more radiation to the normal esophagus when spinal tumors close by are being treated. This may result in better tumor control.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. STAGE 1: \>/= 18 years old
✓. STAGE 1: Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
✓. STAGE 1: Signed informed consent
✓. STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT

Exclusion criteria

✕. STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
✕. STAGE 1: Extensive (\> 50%) height loss of the involved vertebral body
✕. STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes
✕. STAGE 1: Pregnancy
✕. STAGE 2: Prior irradiation of the spine site and level to be treated
✕. STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question
✕. STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula
✕. STAGE 2: Prior radiation to the esophagus

What they're measuring

Assess Use of Implanted Fiducial Markers in Treatment Planning and Delivery Workflow for Frame-Based Spinal Stereotactic Body Radiation Therapy (Spinal SBRT)

Timeframe: 1 month

Trial details

NCT IDNCT01624220

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-14

View on ClinicalTrials.gov More Spinal Tumor trials