Advanced Bulky Malignancies Clinical Trial
Official title:
Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial
| Verified date | April 2015 |
| Source | Summa Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Summa Health System | Akron | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Summa Health System |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Secondary | 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. | No |