Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Summa Health System

Status and phase: Terminated; Phase 2

Conditions: Advanced Bulky Malignancies

Treatments: Radiation: Treatment Group 1; Radiation: Standard radiation; Radiation: Spatially Fractioned Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00765570

GRID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Treatment Group 1

Active Comparator group

Description:

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

Treatment:

Radiation: Spatially Fractioned Radiation Therapy

Radiation: Treatment Group 1

Treatment Group-2

Active Comparator group

Description:

Treatment Group 2-15 treatments with standard radiation

Treatment:

Radiation: Standard radiation

Radiation: Standard radiation