Spinal Stereotactic Body Radiation Therapy

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01624220
First received: June 18, 2012
Last updated: March 11, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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 ] [ 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.



Secondary Outcome Measures:
  • Esophageal Tolerance to Hypofractionation [ 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.



Estimated Enrollment: 57
Study Start Date: June 2012
Estimated Primary Completion Date: June 2016 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624220

Contacts
Contact: Paul Brown, MD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paul Brown, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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: March 11, 2014
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 April 16, 2014