Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy - Full Text View

Sponsored by:	Summa Health System
Information provided by:	Summa Health System
ClinicalTrials.gov Identifier:	NCT00765570

Purpose

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.

Condition	Intervention	Phase
Advanced Bulky Malignacies	Radiation: Spatially Fractioned Radiation Therapy Radiation: Treatment Group 1 Radiation: Standard radiation	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial

Further study details as provided by Summa Health System:

Primary Outcome Measures:

To demonstrate that grid radiation can be given safely at Summa Health System Hospitals complication to patients undergoing palliative radiation of massive tumors. [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess subjective and 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. [ 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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	February 2003
Estimated Study Completion Date:	February 2018
Estimated Primary Completion Date:	February 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group 1: Active Comparator Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation	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
Treatment Group-2: Active Comparator Treatment Group 2-15 treatments with standard radiation	Radiation: Standard radiation 15 Standard radiation treatments Radiation: Standard radiation standard radiation treatment

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765570

Contacts

Contact: Michael Seider, Ph.D., M.D.

330-375-3557

seiderm@summa-health.oth

Locations

United States, Ohio
Summa Health System	Recruiting
Akron, Ohio, United States, 44304
Contact: Michael Sedier, Ph.D., M.D. 330-375-5557 sedierm@summa-health.org
Principal Investigator: Michael Seider, Ph.D., M.D.

Sponsors and Collaborators

Summa Health System

Investigators

Principal Investigator:

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

Summa Health System

More Information

Responsible Party:	Summa Health System ( Michael Seider, Ph.D., M.D. )
Study ID Numbers:	GRID
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00765570
Health Authority:	United States: Institutional Review Board

Keywords provided by Summa Health System:

large tumors in the head & neck, lung, abdomen or pelvis

ClinicalTrials.gov processed this record on January 13, 2009