NCT00765570

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Summa Health System · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Bulky Malignancies

Interventions

Type	Name	Description
RADIATION	Spatially Fractioned Radiation Therapy	evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.
RADIATION	Treatment Group 1	one treatment of Grid therapy followed by 15 treatments with standard radiation
RADIATION	Standard radiation	15 Standard radiation treatments
RADIATION	Standard radiation	standard radiation treatment

Timeline

• Start date: 2003-02-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2008-10-03
• Last updated: 2015-05-18
• Results posted: 2015-03-02

Locations

1 site across 1 country: United States