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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01624220

Recruitment Status : Active, not recruiting

First Posted : June 20, 2012

Last Update Posted : December 2, 2020

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Tumor	Radiation: Spinal SBRT (Standard Dose) Radiation: Spinal SBRT (Higher Dose) Procedure: Gold Seed Implantation Behavioral: Questionnaires	Not Applicable

Show detailed description

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	41 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
Actual Study Start Date :	June 2012
Estimated Primary Completion Date :	December 30, 2021
Estimated Study Completion Date :	December 30, 2022

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Renal Cell Carcinoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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. Other Name: XRT 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. Other Name: Fiducial implantation 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. Other Name: Surveys
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.	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. Other Name: XRT 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. Other Name: Fiducial implantation 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. Other Name: Surveys

Arm

Intervention/treatment

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.

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.

Other Name: XRT

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.

Other Name: Fiducial implantation

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.

Other Name: Surveys

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.

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.

Other Name: XRT

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.

Other Name: Fiducial implantation

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.

Other Name: Surveys

Outcome Measures

Primary Outcome 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 ]
Establish platform and perform analysis of the ExacTrac positioning system with and without fiducial guidance.

Patients monitored at each follow-up visit, with MRI of the spine performed at each follow-up time point during the first year. Treated lesions will be classified as progressive (defined as > 25% increased volume), stable (defined as radiographically unchanged), or smaller, and spinal tumor progression-free survival (PFS) will be calculated.

Secondary Outcome Measures :

Esophageal Tolerance to Hyperfractionation [ Time Frame: 1 month ]
Characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring.

Specific esophageal toxicity endpoints monitored include: dyspepsia, dysphagia, fistula, hemorrhage, necrosis, obstruction, pain, perforation, stenosis, ulcer, varices and esophagitis.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624220

Locations

Layout table for location information

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Layout table for investigator information

Principal Investigator:	Amol J. Ghia, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

Layout table for additonal information

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01624220
Other Study ID Numbers:	2012-0190 NCI-2012-01244 ( Registry Identifier: NCI CTRP )
First Posted:	June 20, 2012 Key Record Dates
Last Update Posted:	December 2, 2020
Last Verified:	December 2020

Keywords provided by M.D. Anderson Cancer Center:


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

Additional relevant MeSH terms:

Layout table for MeSH terms

Spinal Cord Neoplasms Spinal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Spinal Cord Diseases	Central Nervous System Diseases Nervous System Diseases Bone Neoplasms Bone Diseases Musculoskeletal Diseases Spinal Diseases

To Top