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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Bulky Malignancies
Interventions Radiation: Spatially Fractioned Radiation Therapy
Radiation: Treatment Group 1
Radiation: Standard radiation
Enrollment 12
Recruitment Details Subjects were screened and enrolled from the physicians offices at Summa Health System.
Pre-assignment Details  
Arm/Group Title Treatment Group 1 Treatment Group-2
Hide Arm/Group Description Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation Treatment Group 2:15 treatments with standard radiation
Period Title: Overall Study
Started 9 3
Completed 7 3
Not Completed 2 0
Arm/Group Title Treatment Group 1 Treatment Group-2 Total
Hide Arm/Group Description Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation Treatment Group 2: 15 treatments with standard radiation Total of all reporting groups
Overall Number of Baseline Participants 9 3 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  22.2%
1
  33.3%
3
  25.0%
>=65 years
7
  77.8%
2
  66.7%
9
  75.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 3 participants 12 participants
73  (12) 69  (9) 72  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
Female
3
  33.3%
2
  66.7%
5
  41.7%
Male
6
  66.7%
1
  33.3%
7
  58.3%
1.Primary Outcome
Title Protocol Treatment Related Morbidity
Hide Description Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group 1 Treatment Group-2
Hide Arm/Group Description:
Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
Treatment Group 2: 15 treatments with standard radiation
Overall Number of Participants Analyzed 9 3
Measure Type: Number
Unit of Measure: events
Grade 3 Adverse Events 0 0
Grade 4 Adverse Events 0 0
Grade 5 Adverse Events 0 0
2.Secondary Outcome
Title 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.
Hide Description 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)
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group 1 Treatment Group-2
Hide Arm/Group Description:
Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
Treatment Group 2: 15 treatments with standard radiation
Overall Number of Participants Analyzed 9 3
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 1 0
Partial response (PR) 0 1
Stable disease (SD) 6 2
Progressive disease (PD) 1 0
Unknown (UK) 1 0
Time Frame Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group 1 Treatment Group-2
Hide Arm/Group Description Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation Treatment Group 2-15 treatments with standard radiation
All-Cause Mortality
Treatment Group 1 Treatment Group-2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Treatment Group 1 Treatment Group-2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group 1 Treatment Group-2
Affected / at Risk (%) Affected / at Risk (%)
Total   8/9 (88.89%)   2/3 (66.67%) 
Gastrointestinal disorders     
GI or GU Toxicity  1  3/9 (33.33%)  0/3 (0.00%) 
General disorders     
other  1  3/9 (33.33%)  1/3 (33.33%) 
Nervous system disorders     
CNS Toxicity  1  1/9 (11.11%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Lung Toxicity  1 [1]  4/9 (44.44%)  1/3 (33.33%) 
Skin and subcutaneous tissue disorders     
Skin Toxicity  1  6/9 (66.67%)  2/3 (66.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC (2.0)
[1]
cough, dyspnea
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tracy Mondello, MS
Organization: Summa Health System
Phone: 330-375-6131
EMail: mondellot@summahealth.org
Layout table for additonal information
Responsible Party: Summa Health System
ClinicalTrials.gov Identifier: NCT00765570    
Other Study ID Numbers: GRID
First Submitted: October 2, 2008
First Posted: October 3, 2008
Results First Submitted: February 16, 2015
Results First Posted: March 2, 2015
Last Update Posted: May 18, 2015