Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Bulky Malignancies
• Intervention / Treatment: Radiation: Spatially Fractioned Radiation Therapy; Radiation: Treatment Group 1; Radiation: Standard radiation; Radiation: Standard radiation

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment Group 1; Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation	Radiation: 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.; Other Names: GRID Radiation; Radiation: Treatment Group 1; one treatment of Grid therapy followed by 15 treatments with standard radiation
ACTIVE_COMPARATOR: Treatment Group-2; Treatment Group 2-15 treatments with standard radiation	Radiation: Standard radiation; 15 Standard radiation treatments; Other Names: Treatment Group 2; Radiation: Standard radiation; standard radiation treatment; Other Names: Treatment Group 2

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Summa Health System
• Investigators: Principal Investigator: Michael Seider, Ph.D., M.D., Summa Health System

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (ESTIMATE): October 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 18, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: large tumors in the head & neck, lung, abdomen or pelvis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GRID