Brief Summary

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

The goal of the first part of this clinical research study is to learn if the use of gold seed markers can lead to 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.

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: June 2016

Detailed Clinical Trial Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 2 groups of 10 participants will be enrolled in the first part of the study, and up to 2 groups of 10 participants will be enrolled in the second part of the study. Only participants who will receive a single spinal SBRT treatment are eligible for the second part of the study.

The 2 groups of participants in the first part of the study will receive standard doses of radiation therapy to the normal esophagus while treating the tumor. Each new group after that will receive a higher dose of radiation to the esophagus than the group before it, if no intolerable side effects were seen.

Gold Seed Implantation:

A needle will be used to place 4 gold seeds into the bones of your spine: 2 gold seeds above and 2 gold seeds below the area of the tumor to be treated. The area will be numbed with anesthetic or you may receive conscious sedation. No hospital stay is required. Only 1 implantation procedure is necessary.

Radiation Planning and Treatment:

Before starting radiation treatment, you will be asked to complete a questionnaire about any symptoms you might be having and any drugs that you are taking. It should take about 10 minutes to complete. After treatment, you will be given copies of the questionnaire to take with you, and asked to fill it out 1 time a week for the next 4 weeks. You should return the questionnaires by mail. Self-addressed stamped envelopes will be given to you.

During all radiation treatments, the gold seed markers will be used to try and deliver more accurate radiation treatment. You will have 1 to 3 radiation treatment sessions depending on your doctor's decision.

If you are in the second part of the study, you will receive slightly more radiation than usual to the normal esophagus.

The rest of your radiation treatment planning and treatment delivery appointments will be unchanged. The dose given to the tumor and number of treatments you receive will be determined by your doctor, and is not affected by taking part in this study.

Follow-Up Visits:

After your radiation treatment schedule ends, you will return for follow-up visits at the following time points:

- At 3 months

- Then, every 3 months for 1 year

- Every 6 months during year 2, and then

- 1 time a year after that, for as long as possible

Additional follow up visits may be scheduled, if your doctor thinks they are needed.

At these visits, the following tests and procedures will be performed:

- Any updates to your medical history will be recorded and you will be asked about any side effects you may be having.

- Your performance status will be recorded.

- Your completed symptom questionnaires will be reviewed.

- You will have a physical, including measurement of your vital signs

- You will have a neurological exam.

- You will have follow-up imaging (such as an MRI) to check the status of the disease.

This is an investigational study. Gold seed markers are FDA approved and currently used to help line up radiation treatments in multiple parts of the body, including for treatment of prostate cancer. Studying the level of effectiveness of gold seed markers in spinal SBRT is considered investigational.

Radiation therapy is delivered using FDA-approved and commercially available methods. It is considered investigational to give increased radiation to the esophagus.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Interventions Used in this Clinical Trial

• Radiation: Spinal SBRT (Standard Dose)
  • Group 1 and 2: Standard doses of radiation therapy to the normal esophagus while treating the tumor. Up to 2 groups of 10 participants enrolled.
• Radiation: Spinal SBRT (Higher Dose)
  • Group 3 and 4: Higher dose of radiation to esophagus than group before it, if no intolerable side effects were seen. 2 groups of 10 participants enrolled in the second part of study. Only participants who will receive a single spinal SBRT treatment are eligible for second part of study.
• Procedure: Gold Seed Implantation
  • 4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated.
• Behavioral: Questionnaires
  • Completion of questionnaire before radiation treatment starts, and 1 time a week for the next 4 weeks. It should take about 10 minutes to complete.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Hypofractionated Radiation
  • All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor. In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
• Experimental: ExacTrac Positioning System
  • Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.

Outcome Measures for this Clinical Trial

Primary Measures

• Assess Use of Implanted Fiducial Markers in Treatment Planning and Delivery Workflow for Frame-Based Spinal Stereotactic Body Radiation Therapy (Spinal SBRT)
  • Time Frame: 1 month
    Safety Issue?: Yes

Secondary Measures

• Esophageal Tolerance to Hypofractionation
  • Time Frame: 1 month
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. STAGE 1: >/= 18 years old

2. 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

3. STAGE 1: Signed informed consent

4. STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT

Exclusion Criteria

1. STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)

2. STAGE 1: Patients with lesions in the upper cervical spine (C1-C5) or cervicothoracic junction (C6-T3)

3. STAGE 1: Spinal hardware at either a) the vertebral body to be treated or b) one VB above and below

4. STAGE 1: Prior kyphoplasty at either a) the vertebral body to be treated or b) one VB above and below

5. STAGE 1: Extensive (> 50%) height loss of the involved vertebral body

6. STAGE 1: Tumor/vertebral body anatomy precluding fiducial placement

7. STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes

8. STAGE 1: Patients requiring general anesthesia for fiducial placement

9. STAGE 1: Contraindications to seed placement, including uncontrollable bleeding diathesis, elevated INR (> 1.7), or low platelets (< 75 k/µl)

10. STAGE 1: Pregnancy

11. STAGE 2: Prior irradiation of the spine site and level to be treated

12. STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question

13. STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula

14. STAGE 2: Prior radiation to the esophagus

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • M.D. Anderson Cancer Center
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Paul Brown, MD, Principal Investigator, UT MD Anderson Cancer Center
• Overall Contact(s)
  • Paul Brown, MD, 713-563-2300