Advanced Bulky MalignanciesPhase 2NCT00765570
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
A Phase 2 study testing Spatially Fractioned Radiation Therapy, Treatment Group 1 and Standard radiation in people with Advanced Bulky Malignancies, run by Summa Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Bulky Malignancies
- What is being tested?
- Spatially Fractioned Radiation Therapy, Treatment Group 1 and Standard radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial
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.
Read the 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.
- Conditions
- Advanced Bulky Malignancies
- Being tested
- Spatially Fractioned Radiation Therapy, Treatment Group 1, Standard radiation
- Keywords
- large tumors in the head & neck, lung, abdomen or pelvis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractioned Radiation TherapyRadiation
Also called GRID Radiation
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
Also called Treatment Group 2
15 Standard radiation treatments
Standard radiationRadiation
Also called Treatment Group 2
standard radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation Receives: Radiation: Spatially Fractioned Radiation Therapy; Radiation: Treatment Group 1 |
| Treatment Group-2 | Active comparator | Treatment Group 2-15 treatments with standard radiation Receives: Radiation: Standard radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startFeb 2003
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Accrual too slow - would not enroll enough subjects to determine outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Bulky MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Seider, Ph.D., M.D., Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765570
- Sponsor's protocol ID
- GRID
- Status last verified
- Apr 2015
- First submitted
- 2 Oct 2008
- Last updated
- 18 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial
- ClinicalTrials.gov ID
- NCT00765570
- Acronym / sponsor ID
- GRID
- Conditions
- Advanced Bulky Malignancies
- Keywords
- large tumors in the head & neck, lung, abdomen or pelvis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual too slow - would not enroll enough subjects to determine outcome
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Radiation: Spatially Fractioned Radiation Therapy, Radiation: Treatment Group 1Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation |
| Treatment Group-2 | Active comparator | Radiation: Standard radiationTreatment Group 2-15 treatments with standard radiation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatially Fractioned Radiation TherapyAlso: GRID Radiationevaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy. | Radiation | Treatment Group 1 |
| Treatment Group 1one treatment of Grid therapy followed by 15 treatments with standard radiation | Radiation | Treatment Group 1 |
| Standard radiationAlso: Treatment Group 215 Standard radiation treatments | Radiation | Treatment Group-2 |
| Standard radiationAlso: Treatment Group 2standard radiation treatment | Radiation | Treatment Group-2 |
Primary outcome
Protocol Treatment Related Morbidity
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.
Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy
1 secondary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Seider, Ph.D., M.D. principal investigator
Summa Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spatially Fractioned Radiation Therapy, Treatment Group 1 and Standard radiation in people with Advanced Bulky Malignancies, run by Summa Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Treatment Related Morbidity (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.