Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

NCT ID: NCT00765570

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2013-01-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group 1

Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation

Group Type: ACTIVE_COMPARATOR

Spatially Fractioned Radiation Therapy

Intervention Type: RADIATION

evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.

Treatment Group 1

Intervention Type: RADIATION

one treatment of Grid therapy followed by 15 treatments with standard radiation

Treatment Group-2

Treatment Group 2-15 treatments with standard radiation

Group Type: ACTIVE_COMPARATOR

Standard radiation

Intervention Type: RADIATION

15 Standard radiation treatments

Standard radiation

Intervention Type: RADIATION

standard radiation treatment

Interventions

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.

Intervention Type: RADIATION

Treatment Group 1

one treatment of Grid therapy followed by 15 treatments with standard radiation

Intervention Type: RADIATION

Standard radiation

15 Standard radiation treatments

Intervention Type: RADIATION

Standard radiation

standard radiation treatment

Intervention Type: RADIATION

Other Intervention Names

GRID Radiation; Treatment Group 2; Treatment Group 2

Eligibility 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 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Summa Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Summa Health System

Locations

Summa Health System

Akron, Ohio, United States

Countries

United States

Other Identifiers

GRID

Identifier Type: -

Identifier Source: org_study_id