TerminatedPhase 2NCT00765570

Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

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.

Checked against the public recordLast updated May 18, 2015 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorSumma Health System
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Summa Health System
Interventions being studied
Radiation: Spatially Fractioned Radiation Therapy; Radiation: Treatment Group 1; Radiation: Standard radiation; Radiation: Standard radiation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Summa Health SystemAkron, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 18, 2015. Always confirm current availability with the study team.

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