Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Phase 2TerminatedNCT00765570

Summa Health System12 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Bulky Malignancies

Interventions

Spatially Fractioned Radiation TherapyRADIATION

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

Treatment Group 1RADIATION

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

Standard radiationRADIATION

15 Standard radiation treatments

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Summa Health System

Akron, Ohio, United States

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

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)

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.

Data from ClinicalTrials.gov

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