Status:
TERMINATED
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
Lead Sponsor:
Summa Health System
Conditions:
Advanced Bulky Malignancies
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 reduc...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00765570
Start Date
February 1 2003
End Date
January 1 2013
Last Update
May 18 2015
Active Locations (1)
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1
Summa Health System
Akron, Ohio, United States, 44304