Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Stopped early · Phase 2

Conditions studied: Advanced Bulky Malignancies

In brief

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.

Key facts

Study ID

NCT00765570

Run by

Summa Health System

People needed

12

Starts

2003-02-01

Expected to finish

2013-01-01

Last updated by the study team

2015-05-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologic or cytologic diagnosis of primary or metastatic epithelial cancer or sarcoma located in the head and neck area, lung, abdomen or pelvis.
• Tumors must have an overall dimension greater than 24 cm2 (bidimensional) with one dimensions >6 cm, by x-ray, CT/MRI scan or clinical exam.
• Age >18
• Karnofsky > 70 with life expectancy >3 months.
• Patients may not begin new hormone therapy within 2 weeks of initiation of protocol treatment.
• No planned initiation of hormone therapy within 2 weeks of protocol therapy
• Adequate bone marrow function: Hb > 9, white blood cell count (WBC) > 2,000. Hepatic function < 3x upper limit of laboratory normal values.
• Laboratory studies will be obtained within 2 weeks prior to randomization.
• Patients with metastatic sites of disease including brain are eligible provided that life expectancy is > 3 months.

You may not qualify if…

• Hematologic-related tumors.
• Tumors overlying critical central nervous system structures including spinal cord, eye or brainstem or require treatment portals over these vital structures.
• Central nervous system tumors
• Evidence of other primary malignancy except for carcinoma in situ of cervix or skin cancer excluding melanoma unless disease free for 2 years prior to randomization
• Patients with spinal cord compression.
• Prior radiation to treatment field.
• Concomitant chemotherapy or chemotherapy within past 2 weeks. Planned initiation of chemotherapy within 2 weeks of completing protocol treatment

Where it is running

• Summa Health System — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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