High Grade GliomasPhase 2NCT00386919
Short Course of Radiation for Gliomas in Elderly Patients
A Phase 2 study testing CyberKnife in people with High Grade Gliomas, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise, focused radiation with cyberknife. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- High Grade Gliomas
- What is being tested?
- CyberKnife
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2013
- Phase
- Phase 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed High Grade Glioma (oligo-, astro- or mixed gliomas).
- >65 years of age
- KPS>70
- No contraindication for Radiation or Chemotherapy
- Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
- Patient must have recovered from the effects of surgery, post-operative infection, or other complications.
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- Therapy should start within 5 weeks of surgery
- Must have an estimated survival of > 8 weeks.
- KPS > 70.
- Age > 65 years.
- Must have a pre- and post operative contrast enhanced MRI scans
- Laboratory values within the following limits: ANC (absolute neutrophil count) >/= 1.5x 109/l, Platelets >/= 100x 10 9 /L, Hemoglobin >/= 9g/dl, Serum Creatinine >/= 1.5mg/dl., Serum total Bilirubin </= 1.5 x upper limit of normal (ULN), SGOT/SGPT </= 2.5x ULN, Albumin >/= 3g/dl.
- If the patient receiving an enzyme inducing antiepileptic drug will be switched to an NEIAED (Non Enzyme Inducing Anti Epileptic Drug).
Who cannot join
- Histology grade less than Anaplastic Glioma ( WHO Grade III).
- Recurrent malignant glioma.
- Tumor involving the Brain stem.
- Any detected tumor foci beyond the cranial vault.
- Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
- Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for > 5 years.
- Prior radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields.
- Prior chemotherapy for the current disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of Hypofractionated Radiation With CyberKnife Stereotactic Radiosurgery Boost for High Grade Gliomas in Elderly Patients With Good Performance Status
Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise, focused radiation with cyberknife.
Read the detailed description
Screening Procedures: Screening procedures are tests and procedures that will be done to determine if you are eligible to take part in the research study. For this research study, the screening procedures include: Medical history, physical examination including neurological and performance status, assessment of preoperative and postoperative scans, operative reports and pathology reports. All of these have already been performed or will be performed as standard of care for your condition even if you are not taking part in this study.
Research Procedures: If you qualify to take part in this research study, you will undergo these research procedures: The pre- and post operative MRI (Magnetic Resonance Imaging) scans before and after your operation, the operative procedure (including sampling known as biopsy or removal of as much as tumor as possible) and the procedures to facilitate radiation therapy planning (making a mask in the treatment position to keep you comfortably still and CAT scan in the treatment position). These are all part of standard procedures in the treatment of your tumor, whether you are in this study or not.
One of the primary reasons to deliver radiation in multiple small doses conventionally (30-33 treatments over 6-61/2 weeks) is to minimize damage to the surrounding normal brain. The Cyberknife technology allows precise delivery of radiation to your tumor while minimizing radiation to the surrounding brain. This allows the possibility of delivering higher doses of radiation to the tumor thereby shortening the overall treatment time (18 treatments in 31/2 weeks). This is what is being studied in this study.
The Cyberknife treatment will be longer in duration lasting about 30-60 minutes rather than 5-10 minutes with each conventional radiation treatment. During this time you will be asked to lie as comfortably still as you can. The technology however permits the radiation beam to adjust precisely to any small movements you may make to maintain the accuracy.
Along with radiation, you will get chemotherapy called Temozolomide, in the form of pills. This is also standard treatment whether or not you are in this study. You will be asked to take these pills every day during the course of radiation and for 5 days each month thereafter for a year. However during radiation you will be receiving Temozolomide, which is used to possibly make the radiation more effective, only for 4 weeks as opposed to 6 weeks of conventional radiation. As part of usual care with this chemotherapy you may receive supportive medication to prevent and treat nausea, vomiting, low blood counts or infection.
Monitoring/Follow-Up Procedures. Procedures performed to evaluate the effectiveness and safety of the experimental procedures are called "monitoring" or "follow-up" procedures. For this research study, the monitoring/follow-up procedures include: Clinical assessment including neurological and performance status assessments and blood tests for your chemotherapy will be performed every month for the first year and every three months thereafter. MRI scans one month after completion of radiation therapy and every 2 months thereafter. All these procedures are performed routinely in the management of your tumor
- Conditions
- High Grade Gliomas
- Being tested
- CyberKnife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnifeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability of short duration involved field radiation followed by CyberKnife Radiosurgery Boost
Measured: 1 month
Secondary outcomes (1)
Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomasStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Mahadevan, Beth Israel Deaconess Medical Center
- Investigators
- Anand Mahadevan, MD, Principal investigator, Beth Israel Deaconess Medical Center, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386919
- Sponsor's protocol ID
- 2006P-000110/3
- Status last verified
- Jan 2017
- First submitted
- 11 Oct 2006
- Last updated
- 27 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hypofractionated Radiation With CyberKnife Stereotactic Radiosurgery Boost for High Grade Gliomas in Elderly Patients With Good Performance Status
- ClinicalTrials.gov ID
- NCT00386919
- Acronym / sponsor ID
- 2006P-000110/3
- Conditions
- High Grade Gliomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Oct 2006 (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.
Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise, focused radiation with cyberknife.
Detailed description
Screening Procedures: Screening procedures are tests and procedures that will be done to determine if you are eligible to take part in the research study. For this research study, the screening procedures include: Medical history, physical examination including neurological and performance status, assessment of preoperative and postoperative scans, operative reports and pathology reports. All of these have already been performed or will be performed as standard of care for your condition even if you are not taking part in this study.
Research Procedures: If you qualify to take part in this research study, you will undergo these research procedures: The pre- and post operative MRI (Magnetic Resonance Imaging) scans before and after your operation, the operative procedure (including sampling known as biopsy or removal of as much as tumor as possible) and the procedures to facilitate radiation therapy planning (making a mask in the treatment position to keep you comfortably still and CAT scan in the treatment position). These are all part of standard procedures in the treatment of your tumor, whether you are in this study or not.
One of the primary reasons to deliver radiation in multiple small doses conventionally (30-33 treatments over 6-61/2 weeks) is to minimize damage to the surrounding normal brain. The Cyberknife technology allows precise delivery of radiation to your tumor while minimizing radiation to the surrounding brain. This allows the possibility of delivering higher doses of radiation to the tumor thereby shortening the overall treatment time (18 treatments in 31/2 weeks). This is what is being studied in this study.
The Cyberknife treatment will be longer in duration lasting about 30-60 minutes rather than 5-10 minutes with each conventional radiation treatment. During this time you will be asked to lie as comfortably still as you can. The technology however permits the radiation beam to adjust precisely to any small movements you may make to maintain the accuracy.
Along with radiation, you will get chemotherapy called Temozolomide, in the form of pills. This is also standard treatment whether or not you are in this study. You will be asked to take these pills every day during the course of radiation and for 5 days each month thereafter for a year. However during radiation you will be receiving Temozolomide, which is used to possibly make the radiation more effective, only for 4 weeks as opposed to 6 weeks of conventional radiation. As part of usual care with this chemotherapy you may receive supportive medication to prevent and treat nausea, vomiting, low blood counts or infection.
Monitoring/Follow-Up Procedures. Procedures performed to evaluate the effectiveness and safety of the experimental procedures are called "monitoring" or "follow-up" procedures. For this research study, the monitoring/follow-up procedures include: Clinical assessment including neurological and performance status assessments and blood tests for your chemotherapy will be performed every month for the first year and every three months thereafter. MRI scans one month after completion of radiation therapy and every 2 months thereafter. All these procedures are performed routinely in the management of your tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed High Grade Glioma (oligo-, astro- or mixed gliomas).
- >65 years of age
- KPS>70
- No contraindication for Radiation or Chemotherapy
- Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
Key exclusion criteria (8 listed)
- Histology grade less than Anaplastic Glioma ( WHO Grade III).
- Recurrent malignant glioma.
- Tumor involving the Brain stem.
- Any detected tumor foci beyond the cranial vault.
- Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
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 |
|---|---|---|
| CyberKnife | Procedure or surgery | – |
Primary outcome
To assess the tolerability of short duration involved field radiation followed by CyberKnife Radiosurgery Boost
Time frame: 1 month
1 secondary outcome
Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime
Time frame: 6 months
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 27 Jan 2017.
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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.
Anand Mahadevan, MD principal investigator
Beth Israel Deaconess Medical Center, Harvard Medical School
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 CyberKnife in people with High Grade Gliomas, run by Beth Israel Deaconess Medical 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 13 inclusion and 8 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 27 Jan 2017. 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?
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?
To assess the tolerability of short duration involved field radiation followed by CyberKnife Radiosurgery Boost (time frame: 1 month). 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 27 Jan 2017.