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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Advanced Bulky Malignancies

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Trial Information

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


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.


Inclusion Criteria:



- 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 6Adequate bone marrow function: Hb
> 9, 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate that grid radiation can be given safely at Summa Health System Hospitals complication to patients undergoing palliative radiation of massive tumors.

Outcome Time Frame:

during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Summa Health System

Authority:

United States: Institutional Review Board

Study ID:

GRID

NCT ID:

NCT00765570

Start Date:

February 2003

Completion Date:

January 2013

Related Keywords:

  • Advanced Bulky Malignancies
  • large tumors in the head & neck, lung, abdomen or pelvis
  • Neoplasms

Name

Location
Summa Health System Akron, Ohio  44312