Clinical trial NCT00765570: Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
Official title: Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Bulky Malignancies
Keywords: large tumors in the head & neck, lung, abdomen or pelvis
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol Treatment Related Morbidity
timeFrame: 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:
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
affiliation: Summa Health System
name: Michael Seider, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: