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Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765570
Recruitment Status : Terminated (Accrual too slow - would not enroll enough subjects to determine outcome)
First Posted : October 3, 2008
Results First Posted : March 2, 2015
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Summa Health System

Tracking Information
First Submitted Date  ICMJE October 2, 2008
First Posted Date  ICMJE October 3, 2008
Results First Submitted Date  ICMJE February 16, 2015
Results First Posted Date  ICMJE March 2, 2015
Last Update Posted Date May 18, 2015
Study Start Date  ICMJE February 2003
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
Protocol Treatment Related Morbidity [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
To Demonstrate That Grid Radiation Can be Given Safely at Summa Health System Hospitals Complication to Patients Undergoing Palliative Radiation of Massive Tumors. [ Time Frame: 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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
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. [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
To Assess Subjective and 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. [ Time Frame: 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
Official Title  ICMJE Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Bulky Malignancies
Intervention  ICMJE
  • 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 Name: GRID Radiation
  • Radiation: Treatment Group 1
    one treatment of Grid therapy followed by 15 treatments with standard radiation
  • Radiation: Standard radiation
    15 Standard radiation treatments
    Other Name: Treatment Group 2
  • Radiation: Standard radiation
    standard radiation treatment
    Other Name: Treatment Group 2
Study Arms  ICMJE
  • Active Comparator: Treatment Group 1
    Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
    Interventions:
    • Radiation: Spatially Fractioned Radiation Therapy
    • Radiation: Treatment Group 1
  • Active Comparator: Treatment Group-2
    Treatment Group 2-15 treatments with standard radiation
    Interventions:
    • Radiation: Standard radiation
    • Radiation: Standard radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
12
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)
102
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765570
Other Study ID Numbers  ICMJE GRID
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Summa Health System
Study Sponsor  ICMJE Summa Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Seider, Ph.D., M.D. Summa Health System
PRS Account Summa Health System
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP