Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation

Treatment Group 2-15 treatments with standard radiation

evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.

Spatially Fractioned Radiation Therapy

one treatment of Grid therapy followed by 15 treatments with standard radiation

Treatment Group 1

Standard radiation

Michael Seider, Ph.D., M.D.

Expand clinical literature on the use of Grid radiation with conventional external beam therapy. Vast majority of therapy is for palliative care to provide relief from pain, but has also shown a reduction in the size of tumor mass.

This study will evaluate response to radiation therapy by a large bulky tumor is influenced by adding a single dose of 15 Gy grid radiotherapy. To accomplish this, patients with large bulky tumors in the lung, abdomen or pelvis will be randomized to receive either standard palliative radiation or palliative radiation plus a single fraction of grid radiation. Tumor response, pain relief and duration of response, and pain control will be monitored. Toxicity of treatment will also be followed. The hypothesis of this study is that grid radiation will produce a significant improvement in tumor response and pain control that produces no further increase in acute or late toxicity.

Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial

Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy

Complete response (CR) = 100% tumor disappearance Partial response (PR) = \> 50% reduction in size Stable disease (SD) = \< 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = \> 10% increase in size of tumor Unknown Status (UK)

Summa Health System

Treatment Group-2

Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation

Treatment Group 2: 15 treatments with standard radiation

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Tracy Mondello, MS

Grade 3 Adverse Events

Grade 4 Adverse Events

Grade 5 Adverse Events

Protocol Treatment Related Morbidity

Complete Response (CR)

Partial response (PR)

Stable disease (SD)

Progressive disease (PD)

Unknown (UK)

Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.

Treatment Group 2:15 treatments with standard radiation

Overall Study

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Rectal Neoplasms

Disease Attributes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.

Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.

Magnetic resonance-guided focused ultrasound

30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).

Standard Radiation

3.5 weeks concurrent with radiation therapy (institutional standard).

Chemotherapy

William Chu, MD, FRCPC

This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.

Magnetic resonance-guided focused ultrasound (MRg-FU) is a non-invasive, outpatient modality being investigated for the thermal treatment of cancer. In MRg-FU, a specially designed transducer is used to focus a beam of low intensity ultrasound energy into a small volume at a specific target site in the body. MR is used to identify and delineate the tumour, focus the ultrasound beam on the target and provide real-time thermal mapping to ensure accurate heating of the designated target with minimal effect to the adjacent healthy tissue. The focused ultrasound beam produces therapeutic hyperthermia (40-42°C) in the target field causing protein denaturation and cell damage.

Currently, there is no prospective clinical data reported on the use of MRg-FU in the setting of recurrent rectal cancer. Recurrent rectal cancer is a vexing clinical problem. Current retreatment protocols have limited efficacy. The addition of hyperthermia to radiation and chemotherapy may enhance the therapeutic response. With recent advances in technology, the investigators hypothesize that MRg-FU is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer without increased side-effects.

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study

Gastrointestinal and genitourinary toxicities assessed as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 after each MRg-FU treatment and 30, 60 and 90 days post-treatment.

Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.

Patient reported pain will be assessed through completion of the Brief Pain Inventory (BPI) and reporting of analgesic usage after each MRg-FU treatment, monthly post-treatment for three months and every 6 months post-treatment for 3 years.

Patient reported quality of life will be assessed through completion of the European Organization for Research and Treatment of Cancer (EORTC) Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire after each MRg-FU treatment, monthly post-treatment for three months and every 6 months post treatment for 3 years.

Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Philips Medical Systems

William Chu, MD, MSc, FRCPC

Radiation Oncologist, Clinician Investigator

Skin and Connective Tissue Diseases

Rare Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Ultra-hypofractionated whole breast radiotherapy

Eduardo Barbieri

Alayne Yamada, PhD

The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.

Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

To estimate and compare the rate of local recurrence between the experimental and control arms.

Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.

Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.

To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.

To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.

To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using RTOG (Radiation Therapy Oncology Group).

To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.

To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.

Instituto Brasileiro de Controle do Cancer

Principal Investigator

Carcinoma

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially

Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed

Hypofractionation with SIB

Jürgen Dunst, MD

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.

Control Arm:

Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy.

or Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 × 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy.

or Hypofractionated radiotherapy of the breast 16 × 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy.

Experimental Arm:

Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed, total dose within the boost volume 16 × 3.00 Gy.

Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer

Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation

any local or regional recurrence or distant metastasis or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy	NCT00765570	Advanced Bulky ...	Spatially Fract... Treatment Group... Standard radiat... Standard radiat...	18 Years - 80 Years	Summa Health System
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer	NCT02528175	Recurrent Recta...	Magnetic resona... Standard Radiat... Chemotherapy	18 Years -	Sunnybrook Health Sciences Centre
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy	NCT05665920	Malignant Breas...	Ultra-hypofract... Standard Radiat...	18 Years -	Instituto Brasileiro de Controle do Cancer
Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer	NCT02474641	Early-Stage Bre...	Standard Radiat... Hypofractionati...	18 Years -	University Hospital Schleswig-Holstein
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy	NCT00765570	Advanced Bulky ...	Spatially Fract... Treatment Group... Standard radiat... Standard radiat...	18 Years - 80 Years	Summa Health System

Spots Global Cancer Trial Database for standard radiation