Adult Brain TumorPhase 1/2NCT01024907
Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
A Phase 1/2 study testing proton beam radiation therapy, quality-of-life assessment and questionnaire administration in people with Adult Brain Tumor and Adult Brain Stem Glioma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Brain Tumor, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma
- What is being tested?
- proton beam radiation therapy, quality-of-life assessment and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2009to Feb 2014
- Phase
- Phase 1/2
- 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
- Patients with histologically confirmed diagnosis of low grade glioma of the CNS
- Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression
- Patients must have a Karnofsky Performance Status of >= 60
- Patients must be able to provide informed consent
- Patients must have adequate bone marrow function:
- WBC >= 4000/mm^3
- platelets >= 100,000 mm^3
- Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc); Hysterectomy or menopause must be clinically documented
Who cannot join
- Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- Patients with the following histologies:
- gliomatosis cerebrei, WHO III or IV gliomas
- Patients who have had any prior Radiation treatment
- Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date
- Pregnant women, women planning to become pregnant and women that are nursing
- Patients who are actively being treated on any other therapeutic research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Proton Radiation for Low Grade Gliomas
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas. (Phase I)
SECONDARY OBJECTIVES:
- To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) II. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) III. To compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. (Phase II) IV. To monitor the rates of local control, overall and disease specific survival using proton radiotherapy. (Phase II) V. To evaluate the time to progression of low grade gliomas treated with protons. (Phase II) VI. To evaluate the incidence and severity of fatigue in low grade glioma treated with protons. (Phase II) VII. To evaluate the effect of proton beam radiation on neurocognitive outcome in patients with low grade glioma. (Phase II) VIII. To evaluate the quality of life in patients treated for low grade glioma. (Phase II)
OUTLINE: Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
- Conditions
- Adult Brain Tumor, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Grade II Meningioma, Adult Melanocytic Lesion
- Being tested
- proton beam radiation therapy, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Brain Neoplasms, Astrocytoma, Ependymoma, Glioma, Oligodendroglioma, Pinealoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton beam radiation therapyRadiation
Undergo radiation
quality-of-life assessmentProcedure or surgery
Ancillary study
questionnaire administrationOther
Ancillary study
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Radiation: proton beam radiation therapy; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (phase I)
Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)
Measured: 60 days (phase I) or 90 days (phase II) from completion of radiation therapy
Secondary outcomes (6)
Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)
Measured: Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months
Cumulative total dose to normal brain tissue (phase II)
Progression-free survival (phases I and II)
Overall survival (phases I and II)
Adverse events as assessed by NCI CTCAE version 3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study start17 Dec 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Brain TumorStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Lustig, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024907
- Sponsor's protocol ID
- UPCC 08309
- Other IDs
- NCI-2009-01442
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2009
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maquilan G, Grover S, Alonso-Basanta M, Lustig RA. Acute toxicity profile of patients with low-grade gliomas and meningiomas receiving proton therapy. Am J Clin Oncol. 2014 Oct;37(5):438-43. doi: 10.1097/COC.0b013e31827de86b.
PubMed 23388559
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Radiation for Low Grade Gliomas
- ClinicalTrials.gov ID
- NCT01024907
- Acronym / sponsor ID
- UPCC 08309
- Conditions
- Adult Brain Tumor, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Grade II Meningioma, Adult Melanocytic Lesion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 17 Dec 2009 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Dec 2009 (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.
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas. (Phase I)
SECONDARY OBJECTIVES:
- To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) II. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) III. To compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. (Phase II) IV. To monitor the rates of local control, overall and disease specific survival using proton radiotherapy. (Phase II) V. To evaluate the time to progression of low grade gliomas treated with protons. (Phase II) VI. To evaluate the incidence and severity of fatigue in low grade glioma treated with protons. (Phase II) VII. To evaluate the effect of proton beam radiation on neurocognitive outcome in patients with low grade glioma. (Phase II) VIII. To evaluate the quality of life in patients treated for low grade glioma. (Phase II)
OUTLINE: Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: proton beam radiation therapy, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically confirmed diagnosis of low grade glioma of the CNS
- Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression
- Patients must have a Karnofsky Performance Status of >= 60
- Patients must be able to provide informed consent
- Patients must have adequate bone marrow function:
Key exclusion criteria (7 listed)
- Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- Patients with the following histologies:
- gliomatosis cerebrei, WHO III or IV gliomas
- Patients who have had any prior Radiation treatment
- Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date
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 |
|---|---|---|
| proton beam radiation therapyUndergo radiation | Radiation | Arm I |
| quality-of-life assessmentAncillary study | Procedure or surgery | Arm I |
| questionnaire administrationAncillary study | Other | Arm I |
Primary outcome
Feasibility (phase I)
Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)
Time frame: 60 days (phase I) or 90 days (phase II) from completion of radiation therapy
6 secondary outcomes
Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)
Time frame: Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months
Cumulative total dose to normal brain tissue (phase II)
Progression-free survival (phases I and II)
Overall survival (phases I and II)
Adverse events as assessed by NCI CTCAE version 3.0
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 10 Dec 2020.
- Derived from this study: PubMed 23388559Maquilan G, Grover S, Alonso-Basanta M, Lustig RA. Acute toxicity profile of patients with low-grade gliomas and meningiomas receiving proton therapy. Am J Clin Oncol. 2014 Oct;37(5):438-43. doi: 10.1097/COC.0b013e31827de86b.
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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.
Robert Lustig principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing proton beam radiation therapy, quality-of-life assessment and questionnaire administration in people with Adult Brain Tumor and Adult Brain Stem Glioma, run by Abramson Cancer Center at Penn Medicine 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 8 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: finished, as of the sponsor's last update on 10 Dec 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Feasibility (phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024907, which also lists 1 linked publication.
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 10 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.