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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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 advanced bulky malignancies