Clinical trial NCT01624220: A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
Official title: A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Tumor
Keywords: Spinal tumor
Tumor of the mid or lower spine
Non-small cell lung cancer
Breast cancer
Prostate cancer
Renal cell cancer
Melanoma
Gastrointestinal cancer
Sarcoma
Thyroid cancer
Head and neck primary cancer
Carcinoma of unknown primary
Fiducial markers
Gold seed markers
Spinal stereotactic body radiation therapy
Spinal SBRT
Stereotactic Radiotherapy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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 3 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 participants in the first part of the study will receive standard doses of radiation therapy to normal organs while treating the tumor. In the second part of the study, each new group will receive a higher dose of radiation to the esophagus than the group before it, if no intolerable side effects were seen.

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 images that are taken during your treatment will be closely analyzed after treatment is over. 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. Radiation therapy is delivered using FDA-approved and commercially available methods. It is considered investigational to give increased radiation to the esophagus.

Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility criteria: 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: Extensive (\> 50%) height loss of the involved vertebral body
3. STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes
4. STAGE 1: Pregnancy
5. STAGE 2: Prior irradiation of the spine site and level to be treated
6. STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question
7. STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula
8. STAGE 2: Prior radiation to the esophagus

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Esophageal Tolerance to Hyperfractionation
timeFrame: 1 month
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Amol J. Ghia, MD
role: PRINCIPAL_INVESTIGATOR
References: