GlioblastomaSTRONGNCT02039778
Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma
A study testing Stem Cell Radiotherapy (ScRT) and Temozolomide in people with Glioblastoma and Malignant Glioma, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
There are preliminary studies that suggest that radiation therapy to areas of the brain containing cancer stem cells (in addition to the area where the tumor was surgically treated) may help patients with high-grade brain tumors live longer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma, Malignant Glioma, Brain Tumors
- What is being tested?
- Stem Cell Radiotherapy (ScRT) and Temozolomide
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed with high grade glioma (grade 3 or 4) having completed surgery.
- Patients must be ≥ 18 and ≤ 70 years of age;
- WHO/ECOG Performance Status of 2 or less.
- MRI of the brain as delineated above.
- Patients must sign a study-specific informed consent prior to study entry.
Who cannot join
- Evidence of brainstem involvement on radiographs;
- Evidence of oligodendroglioma histology.
- Evidence of progressive disease at the time of study entry;
- Evidence of extracranial distant metastatic disease;
- Prior cranial irradiation;
- Patients may not be entered on other studies that have progression free, disease free, or overall survival as a primary endpoint;
- Patients with synchronous or prior malignancy, other than non-melanomatous skin cancer unless disease free greater than 3 years;
- Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STRONG Trial - Stem Cell Radiotherapy (ScRT) and Temozolomide for Newly Diagnosed High-grade Glioma (HGG): A Prospective, Phase I/II Trial
There are preliminary studies that suggest that radiation therapy to areas of the brain containing cancer stem cells (in addition to the area where the tumor was surgically treated) may help patients with high-grade brain tumors live longer. The purpose of this study is to determine whether the addition of stem-cell radiation therapy to the standard chemoradiation will further improve the outcome. The investigators will collect information about the patient's clinical status, disease control, neurocognitive effects, and quality of life during follow-up in our department.
The purpose of the study is to improve the overall survival patients with newly diagnosed malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The investigators will also measure how patients treated with this novel method of radiation therapy do over time in terms of disease control, potential neurocognitive side effects, overall function, and quality of life.
Read the detailed description
Even after optimal standard treatment, the outcome for patients suffering from glioblastoma (GB) is currently dismal, and temozolomide adds a modest survival benefit at high monetary cost and is accompanied by considerable toxicity. A possible explanation for the failure of radiotherapy to cure GB is the observation that glioma cells migrate widely into healthy bilateral brain tissue from one or more foci of origin. These isolated cells are not detected by current radiological techniques or even imaging and therefore usually not included into the target volume during radiotherapy. In this present study the investigators would like to test the hypothesis that the dose prescribed to the normal tissue stem cell niche in the adult brain will influence the effectiveness of radiotherapy for patients suffering from HGG/GB as these niches may serve as a harbor for radioresistant glioma stem cells, which are the only cells in a HGG believed to able to repopulate a tumor.
The hypothesis is based on previous reports showing that adult normal tissue stem cells reside in the lateral periventricular regions of the lateral ventricles and animal studies reporting that transformation of normal tissues stem cells but not differentiated cells lead to tumor formation. This unique anatomical pattern of the brain that clearly separates stem cell niches as a potential pool of cancer stem cell (CSC's) from differentiated tissue make this an ideal model system to study the impact of radiation dose given to these stem cell niches. Therefore, prospective, randomized clinical trials are needed to address the efficacy and toxicity of including the CSC-containing subventricular region as additional target volumes into treatment plans for patients suffering from HGG/GB. This intervention could dramatically improve the outcomes of patients suffering from progressive, relapsing disease despite our best efforts currently.
- Conditions
- Glioblastoma, Malignant Glioma, Brain Tumors, Anaplastic Astrocytoma
- Being tested
- Stem Cell Radiotherapy (ScRT) and Temozolomide
- Keywords
- Glioblastoma, High-grade Glioma, Brain Tums, Temozolomide, Stem cell radiation therapy, IMRT, Proton beam radiotherapy, Conventional external beam radiotherapy, Quality of Life, Neurocognition
- Medical subject headings
- Glioblastoma, Glioma, Brain Neoplasms, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell Radiotherapy (ScRT) and TemozolomideRadiation
Also called Intensity Modulated Radiation Therapy (IMRT), Temozolomide, Stem Cell Radiotherapy
Stem Cell Radiotherapy (ScRT) and Temozolomide:
The postoperative surgical bed + edema + margin \& the ipsilateral subventricular zone (contoured as a 5mm rim of tissue around the ipsilateral lateral ventricles) will be included within the initial target volume and treated to 46 Gy in 23 fractions. After 46 Gy, the conedown or boost volume (surgical cavity + margin) will be treated to a total of 60 Gy, with seven additional fractions of 2 Gy each (14Gy boost dose).
Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays).
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Radiotherapy and Temozolomide | Experimental | One treatment of 2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy over 6 weeks.
Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays). Receives: Radiation: Stem Cell Radiotherapy (ScRT) and Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).
Measured: 12 months
Progression-free Survival
The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).
Measured: 12 months
Secondary outcomes (3)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The short-and long-term toxicity of ScRT (and compare to historical controls).
Measured: 36 months
Neurocognition
The potential neurocognitive effects of ScRT by the Hopkins Verbal Learning Test (HVLT), Mini-mental status exam (MMSE), Trail Making Tests A/B (TMT), and Controlled Word Association Test (COWAT).
Measured: 36 month
Quality of Life
The impact of ScRT on health-related quality of life (HRQOL) as assessed by EORTC Quality of Life Questionnaire (EORTC QLQ-C30)/Brain Cancer Module (BCM 20), Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and Activities of Daily Living Scale (ADLS) during ScRT.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Poor Accural
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 GlioblastomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Responsible party
- Sponsor
- Investigators
- Ilan Shapira, MD, Principal investigator, St. Luke's - Roosevelt Hospitals& Beth Israel Medical CenterRahul Parikh, MD, Principal investigator, Roosevelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039778
- Sponsor's protocol ID
- 13-0151
- Other IDs
- 13-0151
- Acronym
- STRONG
- Status last verified
- Apr 2017
- First submitted
- 16 Jan 2014
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRONG Trial - Stem Cell Radiotherapy (ScRT) and Temozolomide for Newly Diagnosed High-grade Glioma (HGG): A Prospective, Phase I/II Trial
- ClinicalTrials.gov ID
- NCT02039778
- Acronym / sponsor ID
- STRONG / 13-0151
- Conditions
- Glioblastoma, Malignant Glioma, Brain Tumors, Anaplastic Astrocytoma
- Keywords
- Glioblastoma, High-grade Glioma, Brain Tums, Temozolomide, Stem cell radiation therapy, IMRT, Proton beam radiotherapy, Conventional external beam radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Accural
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are preliminary studies that suggest that radiation therapy to areas of the brain containing cancer stem cells (in addition to the area where the tumor was surgically treated) may help patients with high-grade brain tumors live longer. The purpose of this study is to determine whether the addition of stem-cell radiation therapy to the standard chemoradiation will further improve the outcome. The investigators will collect information about the patient's clinical status, disease control, neurocognitive effects, and quality of life during follow-up in our department.
The purpose of the study is to improve the overall survival patients with newly diagnosed malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The investigators will also measure how patients treated with this novel method of radiation therapy do over time in terms of disease control, potential neurocognitive side effects, overall function, and quality of life.
Detailed description
Even after optimal standard treatment, the outcome for patients suffering from glioblastoma (GB) is currently dismal, and temozolomide adds a modest survival benefit at high monetary cost and is accompanied by considerable toxicity. A possible explanation for the failure of radiotherapy to cure GB is the observation that glioma cells migrate widely into healthy bilateral brain tissue from one or more foci of origin. These isolated cells are not detected by current radiological techniques or even imaging and therefore usually not included into the target volume during radiotherapy. In this present study the investigators would like to test the hypothesis that the dose prescribed to the normal tissue stem cell niche in the adult brain will influence the effectiveness of radiotherapy for patients suffering from HGG/GB as these niches may serve as a harbor for radioresistant glioma stem cells, which are the only cells in a HGG believed to able to repopulate a tumor.
The hypothesis is based on previous reports showing that adult normal tissue stem cells reside in the lateral periventricular regions of the lateral ventricles and animal studies reporting that transformation of normal tissues stem cells but not differentiated cells lead to tumor formation. This unique anatomical pattern of the brain that clearly separates stem cell niches as a potential pool of cancer stem cell (CSC's) from differentiated tissue make this an ideal model system to study the impact of radiation dose given to these stem cell niches. Therefore, prospective, randomized clinical trials are needed to address the efficacy and toxicity of including the CSC-containing subventricular region as additional target volumes into treatment plans for patients suffering from HGG/GB. This intervention could dramatically improve the outcomes of patients suffering from progressive, relapsing disease despite our best efforts currently.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Radiotherapy and Temozolomide | Experimental | Radiation: Stem Cell Radiotherapy (ScRT) and TemozolomideOne treatment of 2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy over 6 weeks. Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with newly diagnosed with high grade glioma (grade 3 or 4) having completed surgery.
- Patients must be ≥ 18 and ≤ 70 years of age;
- WHO/ECOG Performance Status of 2 or less.
- MRI of the brain as delineated above.
- Patients must sign a study-specific informed consent prior to study entry.
Key exclusion criteria (8 listed)
- Evidence of brainstem involvement on radiographs;
- Evidence of oligodendroglioma histology.
- Evidence of progressive disease at the time of study entry;
- Evidence of extracranial distant metastatic disease;
- Prior cranial irradiation;
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 |
|---|---|---|
| Stem Cell Radiotherapy (ScRT) and TemozolomideAlso: Intensity Modulated Radiation Therapy (IMRT), Temozolomide, Stem Cell RadiotherapyStem Cell Radiotherapy (ScRT) and Temozolomide: The postoperative surgical bed + edema + margin \& the ipsilateral subventricular zone (contoured as a 5mm rim of tissue around the ipsilateral lateral ventricles) will be included within the initial target volume and treated to 46 Gy in 23 fractions. After 46 Gy, the conedown or boost volume (surgical cavity + margin) will be treated to a total of 60 Gy, with seven additional fractions of 2 Gy each (14Gy boost dose). Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays). | Radiation | Stem Cell Radiotherapy and Temozolomide |
Primary outcome
Overall Survival
Time frame: 12 months
The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).
Progression-free Survival
Time frame: 12 months
The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).
3 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 36 months
Neurocognition
Time frame: 36 month
Quality of Life
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- 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.
Ilan Shapira, MD principal investigator
St. Luke's - Roosevelt Hospitals& Beth Israel Medical Center
Rahul Parikh, MD principal investigator
Roosevelt Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stem Cell Radiotherapy (ScRT) and Temozolomide in people with Glioblastoma and Malignant Glioma, run by Beth Israel 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 5 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: stopped early, as of the sponsor's last update on 5 Jun 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2017). 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?
Overall Survival (time frame: 12 months). 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?
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 5 Jun 2017.