Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Single Fraction IOeRT

Kyle Arneson, MD

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

See points VIII inclusion/exclusion criteria

Operation:

* Lumpectomy, steninal node biopsy
* IOeRT

After Surgery:

* Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
* Chemotherapy (if indicated)
* Hormone therapy (if indicated)

Follow-Up

* Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.
* Assessements of acute toxicity according to CTC-toxicity scoring system
* Assessments of late toxicity according to LENT-SOMA scoring systems
* Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.

Node Negative, Invasive Breast Cancer Single Fraction IOERT

Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer

Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.

AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up.

Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation.

Avera McKennan Hospital & University Health Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)

MRI-TRUS fusion guided Single Frac HDR

Alfonso Gomez-Iturriaga, MD, PhD

Alfonso Gomez-Iturriaga, MD PhD

Francisco Casquero Ocio, MD PhD

High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in terms of biochemical control, patient survival and toxicity, but there are still certain limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical trial.

The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of cancer control and satisfaction of the patients undergoing the experimental treatment.

Forty nine patients will be recruited for the experimental procedure Quality of Life, tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized procedures and scales. Patient satisfaction with the procedure will be appraised using five-category predetermined Likert scale questions.

Two different types of intermediate analyses will be performed: with 15 and 30 recruited patients.

The experimental treatment tested in this study is very innovative. Since prostate cancer is the most frequent cancer in men in Spain, this trial results are very likely to have a major impact on the standard therapy for prostate cancer in our National Health Service, allowing for a higher number of Hospitals within our country and other countries starting protocols of HDR BT 19Gy in single fraction.

Treatment:

The patient´s treatment will consist of MRI-TRUS fusion single HDR brachytherapy fraction (1 fraction of 1900 cGray).

Brachytherapy performed under general anesthesia as an outpatient procedure

TRUS-MRI fusion:

T2 axial volumetric sequence (VISTA) is imported directly from the picture archiving and communication systems (PACS). Then MR images are reconstructed and segmented. Target volumes (prostate gland, dominant intraprostatic lesions (DILs) Organs at risk (OARs) urethra and rectum are delineated.

A transrectal sagittal volumetric ultrasound image is immediately acquired every 2 degrees, a rapid reconstruction algorithm converts the series of 2D images into a 3D volume, which is then displayed in axial, sagittal and coronal views and transferred to the module of fusion with the MRI.

The MRI images and the real-time sonography examination are displayed on a split-screen with the possibility of overlaying the images live in one image. A graphical user interface is used for rigid manual registration of the ultrasound and MRI volumes. This interface allows for displacements in the three dimensions and rotations, until both images are correctly superimposed.

Then the contoured structures are transferred to the US dataset, and these contours are slightly modified until a perfect matching with the US images is achieved.

Dose prescription:

Ultrasound images with the catheters in place will be exported to Oncentra Prostate. The prostate, Foley catheter and anterior rectal wall will be contoured. Catheters will be reconstructed on the planning system. Anatomy based inverse planning will be used for dwell time optimization.

The homogeneity parameters used for optimization aim are:

-For prostate V100 \> 95%, V150 \<35%, V200 \< 6%, where Vn is the fractional volume of the organ that receives n% of the prescribed dose.

The dose constraints for the organ at risk will be:

* Urethral dmax \< 110% and
* Rectal 1cc \< 60% of prescribed dose.

Endpoints

Feasibility of higher doses administration, toxicity and efficacy will be measured

Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer

Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer

Data to be collected are:

i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize

Quality of life will be measured through validated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC

Data to be collected: urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity

Patients will be followed with PSA at every follow-up;

Patient Satisfaction will be measured with Likert scale question

Hospital de Cruces

Staff physician department of Radiation Oncology

Symptoms and General Pathology

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Pain

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

8.0 Gy in 1 fraction to 8.0 Gy total dose.

3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks.

8 Gy x 1 fraction to 8 Gy total dose in single dose.

single fraction

multiple fractions

The aim of the investigators study was to determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painful bone metastases.

The secondary objectives were to evaluate the frequency, duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.

This prospective, phase III, randomized study was conducted by department of radiation oncology at Marilia Medicine School, São Paulo, Brazil.

Eligibility requirements included:

Age of 18 years or older, histologically proven primary malignancy of any histological type, radiographic evidence of bone metastasis, pain corresponding to the area of bone metastasis, a Karnofsky performance status of at least 40, and an estimated life expectancy of at least 1months.

Histologic diagnosis was established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection.

Radiographic evidence of bone metastasis was required and performed within 8 weeks prior to randomization. Acceptable studies included plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging. Other studies were acceptable with the approval of the principal investigator.

Eligible treatment sites were: pelvis, femur, sacrum and/or sacroiliac joints, tibia, cervical, thoracic or lumbar vertebral bodies, humerus, fibula, radius ± ulna, clavicle, sternum, scapula and púbis.

Patients had a "Worst Pain Score" of \> 5 on a scale of 10 (as scored on the Brief Pain Inventory \[BP\]: 0 = no pain; 10 = worst possible pain) or if BPI is \< 5, had be taking narcotic medications with a daily morphine equivalent dose ≥ 60 mg p.o. Patients receiving systemic therapy were eligible for this study as long as there has been no introduction of any systemic therapy within the 30 days prior to entry into this study.

The patient was ineligible if the systemic agent commences within the 30 days prior to registration. This includes hormonal therapy, chemotherapy, and immunotherapy. Patients were ineligible if the painful area had received prior radiation therapy or palliative surgery, if there was pathologic fracture or impending fracture of the treatment site, or if there was planned surgical fi xation of the bone. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression and/or effacement were not eligible.

Required information before randomization included history and physical examination, Karnofsky performance status, radiographically documented bone metastases within 8 weeks before randomization, and completed Brief Pain Inventory.

RADIATION THERAPY

Treatment Plan

Arm A: 3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks. Arm B: 8.0 Gy in 1 fraction to 8.0 Gy total dose.

Simulation of treatment fields was required prior to the first treatment. Prior to the first treatment, an acceptable simulator and portal film documenting that the treatment site was adequately covered and verified by the treating radiation oncologist.

Treatment was given using megavoltage equipment with Cobalt-60 or 6-Mev photons. The minimum Source-Axis Distance (SAD) was 80 cm. All fields were treated each day. Treatment volume was including the radiographic abnormality with at least a 2 cm margin. Treatment of the entire bone is not required. Anterior and posterior parallel opposed fields were used for lumbar spine, sacrum, pelvis, and extremity sites. Equal weighting was recommended, although unequal weighting was used for the lumbar or sacral spine with a ratio of doses of 1:2 AP:PA. Dose was prescribed at mid thickness at the central axis, or at the center of target volume if unequal weighting is used. The cervical spine was treated with either parallel opposed lateral fields or with a single posterior field. When lateral fields were used, the isocenter should be at mid-thickness, with the dose prescribed to the mid-vertebral body. For a single posterior field, the dose was prescribed at a depth of 5 cm or other depth as determined from a lateral simulator film. When more than one osseous site was included into one treatment field, the treating radiation oncologist used differing field arrangements at her/his discretion, with the fields arranged to provide relatively uniform treatment of the target sites with a minimum of uninvolved normal tissues.

Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.

Phase III Study of Palliative Radiotherapy for Bone Metastases Comparing Single to Multiple Fractions.

Marilia Medicine School

Gustavo Viani Arruda

Recurrence

Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction

IPAS

Jean-Michel HANNOUN LEVI, Phd

Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. At least eight phase III trials attempting to answer this question and thus provide a sufficient level of evidence to make this concept a new standard of care for sub-groups of patients well defined (1).

However, without waiting for the final results of these randomized trials (which will not be fully valid with a drop of at least ten years), the American societies (ASTRO) and European (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups according to the risk to the patient in terms of local recurrence after IPAS. And are defined by the ESTRO:

* The low-risk group ("suitable" for ASTRO)
* The intermediate-risk group ("cautionary" in ASTRO)
* The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group "low risk." The results of phase II trials as a long-term analysis of the matched team of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation photons in low energy X whose results were recently published (5) confirm the value of this new therapeutic concept for post-operative breast cancer at low risk of local recurrence.

In France, the therapists were quickly directed to a sub-population for which the IPAS could represent a real improvement in the therapeutic management in significantly reducing the number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6). Several French phase II trials were started specifically targeting the female population aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9).

On a technical level, two main approaches are used (10):

* Irradiation intraoperative electron or low-energy photons,
* Radiation after surgery The advantage of intraoperative irradiation is the optimal reduction of total processing time radio-surgery because the patient is irradiated during the lumpectomy. However, 15-20% of these patients receive partial breast irradiation, as histo-prognostic criteria provided in the histologically final report, confirm the non-adapted indication of IPAS (5).

In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days separated by at least 6 hours).

Single dose intraoperative issued by electrontherapy or low energy photons (50 Kv) is 21 Gy (5.11). However, these doses reported in the irradiated volume are not equivalent. Indeed, with electrontherapy, it is a complete volume of mammary parenchyma that is irradiated, whereas with low energy photon therapy (X 50 KV) is a "shell" of 5 mm thick which is treated knowing that to 10 mm from the surface of the sphere of treatment, the gland received only 50% of the dose initially prescribed. On interstitial brachytherapy with high dose rate, it has a dose escalation due to intrinsic volumes located within the irradiated area that will receive a higher dose than prescribed (12). It is this variation in dose within the target volume which can be efficiency, but also which can induce the toxicity of interstitial brachytherapy. The linear quadratic model to calculate the biological equivalence of 2 Gy irradiation scheme most often hypofractionned, is theoretically applicable for doses per fraction less than 8 Gy. Nevertheless, the authors using the IPAS intra-operative (electrons, photons) apply this method of calculation for doses of 21 Gy in one fraction.

In our study, we propose to treat these patients with a total dose of 16 Gy in one fraction. This dose is calculated taking into account a report alpha/beta for the breast, on the order of 3.4 Gy for late toxicity and 4.6 Gy for local control (13). Applying the linear-quadratic model with alpha/beta for the breast of 4, 16 Gy in one fraction is calculated as radio-biologically equivalent to 53 Gy in conventional fractionation (14,15). Biological Equivalence of this dose is between the dose in the protocols IPAS intraoperative electron or X-ray photons of 50 kV (21 Gy in one fraction, 87 Gy EQD2 alpha/beta 4.6) (5.8) and the post-operative irradiation of 34-38 Gy in 10 fractions, 5 days (42 Gy EQD2 alpha/beta 4.6.

Single Fraction Elderly Breast Irradiation (SiFEBI)

A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence

Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.

Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.

Analysis of the impact on self assessment by onco-geriatric aesthetic result evaluation Dosimetric data analysis in order to propose dose constraints for future inverse planning

Centre Antoine Lacassagne

Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction

IPAS

Age, Categorical

Age, Continuous

Sex: Female, Male

France

Region of Enrollment

Professeur JM Hannoun-Levi

Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)

Evaluation of the Quality of Life

Irradiation and Accelerated Partial Breast (IPAS)

Overall Study

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.

Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.

Stereotactic Body Radiation Therapy (SBRT)

Marianna Perna

Tatiana Carvalho

Fabio Cury, MD

Luis Souhami, MD

Marie Duclos, MD

Sergio Faria, MD

It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment.

Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

There is a pre-treatment visit to the radiation oncology department. A gel is injected between the prostate and the rectum. This procedure is done with the use of a transrectal ultrasound, similarly to the prostate biopsy the patient had. A local anesthetic will be applied to numb the skin and to the underneath tissue where the injection will be performed. The procedure itself will take approximately 20 minutes and after a short observation time, the patient returns home.

The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment.

A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.

Single Fractions SBRT for Prostate Cancer

Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

To assess acute gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;

Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;

gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;and GU toxicity such as Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;

To assess the rate of biochemical control

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Node Negative, Invasive Breast Cancer Single Fraction IOERT	NCT02370797	Breast Cancer	Single Fraction...	60 Years -	Avera McKennan Hospital & University Health Center
Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer	NCT02342054	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Hospital de Cruces
Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.	NCT00858741	Bone Metastases Pain	single fraction multiple fracti...	18 Years -	Marilia Medicine School
Single Fraction Elderly Breast Irradiation (SiFEBI)	NCT01727011	Breast Cancer	IPAS	70 Years -	Centre Antoine Lacassagne
Single Fractions SBRT for Prostate Cancer	NCT04004312	Prostate Cancer	Stereotactic Bo...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer	NCT02342054	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Hospital de Cruces

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