Advanced Bulky Malignancies
Conditions
Keywords
large tumors in the head & neck, lung, abdomen or pelvis
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.
Interventions
RADIATIONSpatially Fractioned Radiation Therapy
evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.
RADIATIONTreatment Group 1
one treatment of Grid therapy followed by 15 treatments with standard radiation
RADIATIONStandard radiation
15 Standard radiation treatments
Sponsors
Summa Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Treatment Related Morbidity | 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. | Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled from the physicians offices at Summa Health System.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group 1 Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation | 9 |
| Treatment Group-2 Treatment Group 2: 15 treatments with standard radiation | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | Treatment Group 1 | Treatment Group-2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 2 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 73 years STANDARD_DEVIATION 12 | 69 years STANDARD_DEVIATION 9 | 72 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 9 | 2 / 3 |
| serious Total, serious adverse events | 0 / 9 | 0 / 3 |
Outcome results
Primary
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group 1 | Protocol Treatment Related Morbidity | Grade 3 Adverse Events | 0 events |
| Treatment Group 1 | Protocol Treatment Related Morbidity | Grade 4 Adverse Events | 0 events |
| Treatment Group 1 | Protocol Treatment Related Morbidity | Grade 5 Adverse Events | 0 events |
| Treatment Group-2 | Protocol Treatment Related Morbidity | Grade 3 Adverse Events | 0 events |
| Treatment Group-2 | Protocol Treatment Related Morbidity | Grade 4 Adverse Events | 0 events |
| Treatment Group-2 | Protocol Treatment Related Morbidity | Grade 5 Adverse Events | 0 events |
Secondary
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group 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. | Partial response (PR) | 0 participants |
| Treatment Group 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. | Progressive disease (PD) | 1 participants |
| Treatment Group 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. | Stable disease (SD) | 6 participants |
| Treatment Group 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. | Unknown (UK) | 1 participants |
| Treatment Group 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. | Complete Response (CR) | 1 participants |
| Treatment Group-2 | 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. | Unknown (UK) | 0 participants |
| Treatment Group-2 | 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) | 0 participants |
| Treatment Group-2 | 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. | Partial response (PR) | 1 participants |
| Treatment Group-2 | 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. | Stable disease (SD) | 2 participants |
| Treatment Group-2 | 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. | Progressive disease (PD) | 0 participants |