GlioblastomaNCT02575027
Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
A study testing Palliative Radiation Therapy, Questionnaire Administration and Radiation Therapy Treatment Planning and Simulation in people with Glioblastoma and Recurrent Brain Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Recurrent Brain Neoplasm
- What is being tested?
- Palliative Radiation Therapy, Questionnaire Administration and Radiation Therapy Treatment Planning and Simulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2014to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary glioblastoma multiforme (GBM)
- Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
- Patient must be diagnosed with recurrent GBM either with biopsy or radiographically
- Karnofsky Performance Status (KPS) >= 70
- Ability to understand and willingness to sign a written informed consent
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
- For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation)
Who cannot join
- Patients with active infection
- Patients with KPS < 70 and/or unable to tolerate potentially longer treatment times
- Refusal to sign informed consent
- Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
- Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: 4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial
This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the accuracy of dose delivery and patient comfort with treatment time.
II. To evaluate normal tissue dose volume statistics and compare to standard planning.
OUTLINE:
Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.
After completion of study treatment, patients are followed up at 6 weeks.
- Conditions
- Glioblastoma, Recurrent Brain Neoplasm
- Being tested
- Palliative Radiation Therapy, Questionnaire Administration, Radiation Therapy Treatment Planning and Simulation
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Radiation TherapyRadiation
Undergo 4pi palliative radiotherapy
Questionnaire AdministrationOther
Ancillary studies
Radiation Therapy Treatment Planning and SimulationRadiation
Also called Radiation Therapy Treatment Planning/Simulation
Undergo 4pi radiation simulation and planning
| Study group | Role | What they receive |
|---|---|---|
| Treatment (4pi radiotherapy) | Experimental | Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation. Receives: Radiation: Palliative Radiation Therapy; Other: Questionnaire Administration; Radiation: Radiation Therapy Treatment Planning and Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of dose delivery
The accuracy of dose delivery by 4pi will be compared to standard procedures. Standard quality assurance (QA) procedures will be employed to validate the delivery accuracy of 4pi. Specifically, a MatriXX phantom will be employed to measure the dose in both the coronal and sagittal planes and compared to calculation. Patients with QA results showing gamma passing rates (using 3% and 3 mm dose difference and distance to agreement criteria, respectively) less than 90% in either plane or a maximum single gamma value greater than 2 will not be treated until the source of error is corrected.
Measured: Up to 6 weeks
Normal tissue dose volume
Statistics will be compared between 4pi and standard planning. Specifically, dose to organs-at-risk (OAR) and planning target volume (PTV) coverage will be compared to assess for improved OAR sparing and improved PTV coverage with 4pi planning.
Measured: Up to 6 weeks
Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start12 Nov 2014
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tania Kaprealian, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575027
- Sponsor's protocol ID
- 14-001086
- Other IDs
- NCI-2015-01449, 14-001086, P30CA016042
- Status last verified
- Feb 2019
- First submitted
- 12 Oct 2015
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT02575027
- Acronym / sponsor ID
- 14-001086
- Conditions
- Glioblastoma, Recurrent Brain Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.
Detailed description
PRIMARY OBJECTIVES:
- To determine the accuracy of dose delivery and patient comfort with treatment time.
II. To evaluate normal tissue dose volume statistics and compare to standard planning.
OUTLINE:
Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.
After completion of study treatment, patients are followed up at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (4pi radiotherapy) | Experimental | Radiation: Palliative Radiation Therapy, Other: Questionnaire Administration, Radiation: Radiation Therapy Treatment Planning and SimulationPatients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed primary glioblastoma multiforme (GBM)
- Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
- Patient must be diagnosed with recurrent GBM either with biopsy or radiographically
- Karnofsky Performance Status (KPS) >= 70
- Ability to understand and willingness to sign a written informed consent
Key exclusion criteria (5 listed)
- Patients with active infection
- Patients with KPS < 70 and/or unable to tolerate potentially longer treatment times
- Refusal to sign informed consent
- Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
- Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible
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 |
|---|---|---|
| Palliative Radiation TherapyUndergo 4pi palliative radiotherapy | Radiation | Treatment (4pi radiotherapy) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (4pi radiotherapy) |
| Radiation Therapy Treatment Planning and SimulationAlso: Radiation Therapy Treatment Planning/SimulationUndergo 4pi radiation simulation and planning | Radiation | Treatment (4pi radiotherapy) |
Primary outcome
Accuracy of dose delivery
Time frame: Up to 6 weeks
The accuracy of dose delivery by 4pi will be compared to standard procedures. Standard quality assurance (QA) procedures will be employed to validate the delivery accuracy of 4pi. Specifically, a MatriXX phantom will be employed to measure the dose in both the coronal and sagittal planes and compared to calculation. Patients with QA results showing gamma passing rates (using 3% and 3 mm dose difference and distance to agreement criteria, respectively) less than 90% in either plane or a maximum single gamma value greater than 2 will not be treated until the source of error is corrected.
Normal tissue dose volume
Time frame: Up to 6 weeks
Statistics will be compared between 4pi and standard planning. Specifically, dose to organs-at-risk (OAR) and planning target volume (PTV) coverage will be compared to assess for improved OAR sparing and improved PTV coverage with 4pi planning.
Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
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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.
Tania Kaprealian principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Radiation Therapy, Questionnaire Administration and Radiation Therapy Treatment Planning and Simulation in people with Glioblastoma and Recurrent Brain Neoplasm, run by Jonsson Comprehensive Cancer Center 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of dose delivery (time frame: Up to 6 weeks). The study lists 3 primary outcomes in all. 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 28 Feb 2019.