Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Bulky Malignancies

Intervention / Treatment
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* Radiation: Spatially Fractioned Radiation Therapy
* Radiation: Treatment Group 1
* Radiation: Standard radiation
* Radiation: Standard radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group 1<br>Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation | Radiation: Spatially Fractioned Radiation Therapy<br>* evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.<br>* Other names: GRID Radiation;Radiation: Treatment Group 1<br>* one treatment of Grid therapy followed by 15 treatments with standard radiation<br>|
| Active Comparator: Treatment Group-2<br>Treatment Group 2-15 treatments with standard radiation | Radiation: Standard radiation<br>* 15 Standard radiation treatments<br>* Other names: Treatment Group 2;Radiation: Standard radiation<br>* standard radiation treatment<br>* Other names: Treatment Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol Treatment Related Morbidity | Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Complete response (CR) = 100% tumor disappearance Partial response (PR) = > 50% reduction in size Stable disease (SD) = < 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = > 10% increase in size of tumor Unknown Status (UK) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large tumors in the head & neck, lung, abdomen or pelvis