Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

NCT00765570 | Terminated Phase 2 Results

• 1 other identifier: GRID
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Bulky Malignancies

Keywords

large tumors in the head & neck, lung, abdomen or pelvis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Treatment Group 1

ACTIVE COMPARATOR

Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation

Radiation: Spatially Fractioned Radiation Therapy; Radiation: Treatment Group 1

Treatment Group-2

ACTIVE COMPARATOR

Treatment Group 2-15 treatments with standard radiation

Radiation: Standard radiation

Interventions

Spatially Fractioned Radiation Therapy RADIATION

evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.

Also known as: GRID Radiation

Treatment Group 1

Treatment Group 1 RADIATION

one treatment of Grid therapy followed by 15 treatments with standard radiation

Treatment Group 1

Standard radiation RADIATION

15 Standard radiation treatments

Also known as: Treatment Group 2

Treatment Group-2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, United States

Location

Results Point of Contact

• Title: Tracy Mondello, MS
• Organization: Summa Health System

mondellot@summahealth.org

330-375-6131

Study Officials

• Michael Seider, Ph.D., M.D.

  Summa Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: February 1, 2003
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 18, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-04

Locations

US (1)