Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Sarcoma

Spinal Cord Neoplasms

Spinal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

Renal Cell Carcinoma

Soft Tissue Sarcoma

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.

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.

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.

Spinal SBRT (Standard 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.

Spinal SBRT (Higher Dose)

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

Gold Seed Implantation

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.

Questionnaires

Amol J. Ghia, MD

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.

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.

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

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.

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.

M.D. Anderson Cancer Center

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

Both are imaging probe devices that is inserted under local anesthetic, in the rectum using lubricant, positioning against the prostate gland, and attached to the table. This is done at baseline (Day 0) under local anesthetic with the patient in partial dorsal lithotomy position

Transrectal APT Device or Transperineal Device will be used

Patient is given local anesthetic transrectally to the prostate base and the probe is inserted with patient in the lateral decubitus position.

TRUS probe

Peter Chung, MD

This purpose of this study is designed to compare two types of images; magnetic resonance imaging (MRI) and Trans-Rectal Ultrasound (TRUS) to see which one performs more accurately for the image-guided insertion of Fiducial Markers(FMs) within the tumour. Though effective for guiding FM placement at the poles of the prostate gland due to excellent visualization of the prostatic boundaries, TRUS may not be ideally suited for marking the GTV. Conventional TRUS is neither sufficiently sensitive nor specific for accurate visualization of intra-prostatic tumor. A new interventional MRI technique enables needle guidance to the gross tumour Volume (GTV) for FM placement. It is of particular importance that both techniques be evaluated to enable which one is more effective so that it can be implemented in the designs of future trials involving dose-escalation to prostate.

The success of dose escalation strategies in prostate cancer over the last decade has relied on high accuracy in target delineation, localization and radiation delivery. Improved biochemical control with acceptable levels of toxicity (specifically rectal) has been achieved by stringently monitoring the location of the prostate during the course of radiation treatment. Studies in the early 1990's demonstrated that daily bony alignment was a poor surrogate for prostate gland location. Since then, various strategies have been devised to localize the prostate precisely during treatment. Of these, Transrectal Ultrasound (TRUS)-guided gold fiducial marker (FM) insertion and x-ray imaging of markers has been a broadly successful approach. TRUS guidance has been used for fiducial marker insertion within the prostate since 1985 in various centers throughout the world and has also been a standard practice in PMH since 1997 in men undergoing radical external beam radiotherapy. A retrospective comparative study of 106 patients evaluating the relative accuracy of endorectal MRI and TRUS in detecting the location of tumor reported an improved performance of endorectal MRI especially in the base and midgland regions. Over the last few years, mounting experience in the interpretation of prostate MRI, and addition of physiologic imaging sequences has further improved the performance of MRI in detecting and localizing the GTV.

Fiducial Localization and Individualized Radiotherapy -Prostate Cancer

Fiducial Localization and Individualized Radiotherapy in Prostate Cancer (FLIP)

Princess Margaret Hospital, Canada

University Health Network, Toronto

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation.

Fiducial markers

Insertion of Fiducial markers in esophageal wall.

Fiducial markers, Pet and MRI

Francine Voncken, MD

To quantify motion based variation of the target volume of the primary tumor over the course of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate appropriate PTV (planning target volume) margins according to the margins recipe for patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation in order to personalize radiation treatment, resulting in either better target coverage or a reduction in normal tissue radiation exposure.

A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans.

Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response.

Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.

Organ Motion and Early Tumor Response Measurement

Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer

data of two clinic trials will be joined for MRI scans

The outcome measures will be assessed by tracking the motion of the fiducial markers at the daily 4D CBCT (four dimensional cone beam CT scan). (primary outcome)

By observing the motion of the fiducial, the exact setup error, breathing motion amplitudes, intra- and inter-fraction motion can be assessed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy	NCT01624220	Spinal Tumor	Spinal SBRT (St... Spinal SBRT (Hi... Gold Seed Impla... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Fiducial Localization and Individualized Radiotherapy -Prostate Cancer	NCT00789607	Prostate Cancer	Transrectal APT... TRUS probe	18 Years -	University Health Network, Toronto
Organ Motion and Early Tumor Response Measurement	NCT02139488	Esophageal Canc... Chemoradiation	Fiducial marker... Fiducial marker...	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for fiducial markers