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

NCT01624220 | Completed

• 2 other identifiers: 2012-0190NCI-2012-01244
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Assess Use of Implanted Fiducial Markers in Treatment Planning and Delivery Workflow for Frame-Based Spinal Stereotactic Body Radiation Therapy (Spinal SBRT)

  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.

  1 month

Secondary Outcomes (1)

• Esophageal Tolerance to Hyperfractionation

  1 month

Study Arms (2)

Hypofractionated Radiation

EXPERIMENTAL

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); Procedure: Gold Seed Implantation; Behavioral: Questionnaires

ExacTrac Positioning System

EXPERIMENTAL

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); Procedure: Gold Seed Implantation; Behavioral: Questionnaires

Interventions

Spinal SBRT (Standard Dose) RADIATION

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.

Also known as: XRT

ExacTrac Positioning System

Spinal SBRT (Higher Dose) RADIATION

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.

Also known as: XRT

Hypofractionated Radiation

Gold Seed Implantation PROCEDURE

4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated.

Also known as: Fiducial implantation

ExacTrac Positioning System; Hypofractionated Radiation

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

ExacTrac Positioning System; Hypofractionated Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Spinal Cord Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms; Carcinoma, Renal Cell; Melanoma; Gastrointestinal Neoplasms; Sarcoma; Thyroid Neoplasms; Neoplasms, Unknown Primary

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective and Soft Tissue; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amol J. Ghia, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: June 18, 2012
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-04

Locations

US (1)