Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Phase 2

Terminated

• Conditions: Advanced Bulky Malignancies
• Interventions: Radiation: Spatially Fractioned Radiation Therapy; Radiation: Standard radiation; Radiation: Treatment Group 1

• Registration Number: NCT00765570
• Lead Sponsor: Summa Health System

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2015-02-16
• Results First Submitted QC: 2015-02-16
• Results First Posted: 2015-03-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Spatially Fractioned Radiation Therapy	Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
Treatment Group 1	Treatment Group 1	Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
Treatment Group-2	Standard radiation	Treatment Group 2-15 treatments with standard radiation

Primary Outcome Measures

Name	Time	Method
Protocol Treatment Related Morbidity	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.	Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy

Secondary Outcome Measures

Name	Time	Method
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.	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.	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)

Trial Locations

Locations (1)

Summa Health System; 🇺🇸 Akron, Ohio, United States