A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
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Purpose
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 | Intervention |
|---|---|
|
Spinal Tumor |
Radiation: Spinal SBRT (Standard Dose) Radiation: Spinal SBRT (Higher Dose) Procedure: Gold Seed Implantation Behavioral: Questionnaires |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: Yes ]
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.
- Esophageal Tolerance to Hyperfractionation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
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.
| Enrollment: | 41 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01624220
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Amol J. Ghia, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01624220 History of Changes |
| Other Study ID Numbers: | 2012-0190 NCI-2012-01244 |
| Study First Received: | June 18, 2012 |
| Last Updated: | September 15, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
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 |
ClinicalTrials.gov processed this record on September 28, 2016