Proton Radiation For Meningiomas and Hemangiopericytomas
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2010 |
| Contact: | Robert Lustig, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas
This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III
Meningioma & Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy.
The study will be performed in two phases: first, feasibility with an enrollment of 12
patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients.
All patients will also be given quality of life (QOL) instruments pretreatment, weekly
during treatment, then q 3 months for year 1 post treatment, q6 months year 2 & 3 and yearly
for year 4 & 5. Comparisons will be made between the enrolled subjects receiving proton
therapy and the known literature on photon radiation. See section 2 for full objectives. The
second phase will begin no earlier than 60 days after the last patient in the initial phase
has completed treatment and once safety and feasibility has been verified. The secondary
objectives will serve as the objectives for the second phase of the study.
Meningioma & Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy.
The study will be performed in two phases: first, feasibility with an enrollment of 12
patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients.
All patients will also be given quality of life (QOL) instruments pretreatment, weekly
during treatment, then q 3 months for year 1 post treatment, q6 months year 2 & 3 and yearly
for year 4 & 5. Comparisons will be made between the enrolled subjects receiving proton
therapy and the known literature on photon radiation. See section 2 for full objectives. The
second phase will begin no earlier than 60 days after the last patient in the initial phase
has completed treatment and once safety and feasibility has been verified. The secondary
objectives will serve as the objectives for the second phase of the study.
Primary Objectives:
The primary objectives of this study are feasibility and safety. The study will be deemed
infeasible if greater than 10% of pts experience one of the following:
- Patient cannot be given treatment because anatomy is such that a dosimetrically
satisfactory treatment plan cannot be devised.
(95% of target volume covered by 95% of the dose)
- Patient is unable to tolerate 20% of treatments (for any reason unable to set patient
up within acceptable limits of tolerance, patient unable to tolerate treatment position
or immobilization for duration of treatment) using proton radiotherapy (up to 80% of
treatments could be delivered using photons).
- Patient is unable to complete all of his/her treatments within 7 days of estimated date
of treatment completion or requires a treatment break greater than 5 days. Toxicity
will be deemed unacceptable if greater than 20% of patients experience acute toxicity,
as defined in Section 7.12.
Secondary Objectives:
- To assess acute side effects from irradiation using proton beam therapy in place of
conventional photon beam therapy for the treatment of meningiomas.
- To assess quality of life outcomes, with a focus on the rate of severe fatigue at 6 and
12 months from end of treatment.
- To assess late complications from irradiation using proton beam therapy in place of
conventional photon beam therapy for the treatment of meningiomas.
- To compare the dose distribution to tumor and surrounding normal structures using DVHs
(Dose Volume Histograms) generated from the proton plan used to treat the patient and
the photon plan generated for comparison purposes.
- To determine 1-yr local control and progression-free and overall survival using proton
radiotherapy.
The primary objectives of this study are feasibility and safety. The study will be deemed
infeasible if greater than 10% of pts experience one of the following:
- Patient cannot be given treatment because anatomy is such that a dosimetrically
satisfactory treatment plan cannot be devised.
(95% of target volume covered by 95% of the dose)
- Patient is unable to tolerate 20% of treatments (for any reason unable to set patient
up within acceptable limits of tolerance, patient unable to tolerate treatment position
or immobilization for duration of treatment) using proton radiotherapy (up to 80% of
treatments could be delivered using photons).
- Patient is unable to complete all of his/her treatments within 7 days of estimated date
of treatment completion or requires a treatment break greater than 5 days. Toxicity
will be deemed unacceptable if greater than 20% of patients experience acute toxicity,
as defined in Section 7.12.
Secondary Objectives:
- To assess acute side effects from irradiation using proton beam therapy in place of
conventional photon beam therapy for the treatment of meningiomas.
- To assess quality of life outcomes, with a focus on the rate of severe fatigue at 6 and
12 months from end of treatment.
- To assess late complications from irradiation using proton beam therapy in place of
conventional photon beam therapy for the treatment of meningiomas.
- To compare the dose distribution to tumor and surrounding normal structures using DVHs
(Dose Volume Histograms) generated from the proton plan used to treat the patient and
the photon plan generated for comparison purposes.
- To determine 1-yr local control and progression-free and overall survival using proton
radiotherapy.
Inclusion Criteria:
- Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
1. WHO grade I :
- Tumor that are newly diagnosed and tumors that are incompletely excised
- Tumors that have recurred post resection
2. WHO grade II:
- Any tumor, either completely or incompletely excised
- Any recurrent tumor
3. WHO grade III and hemangiopericytoma:
- Any tumor, either completely or incompletely excised
- Any recurrent tumor
- Patients must have a Karnofsky Performance Status of 60. Age greater than 18 years
Patients must be able to provide informed consent.
- Adequate bone marrow function: WBC greater than 4000/mm3, platelets greater than
100,000 mm3.
- 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.
Exclusion Criteria:
- Prior or simultaneous malignancies within the past two years (other than cutaneous
squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma).
- Pregnant women, women planning to become pregnant and women that are nursing.
Actively being treated on any other therapeutic research study.
- Prior radiation to the brain.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Phone: 855-216-0098
Click here to add this to my saved trials
