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Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma (STRONG)

Primary Purpose

Glioblastoma, Malignant Glioma, Brain Tumors

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stem Cell Radiotherapy (ScRT) and Temozolomide
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, High-grade Glioma, Brain Tums, Temozolomide, Stem cell radiation therapy, IMRT, Proton beam radiotherapy, Conventional external beam radiotherapy, Quality of Life, Neurocognition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Roosevelt Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell Radiotherapy and Temozolomide

Arm Description

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).

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).
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.

Full Information

First Posted
January 16, 2014
Last Updated
April 28, 2017
Sponsor
Beth Israel Medical Center
Collaborators
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT02039778
Brief Title
Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma
Acronym
STRONG
Official Title
STRONG Trial - Stem Cell Radiotherapy (ScRT) and Temozolomide for Newly Diagnosed High-grade Glioma (HGG): A Prospective, Phase I/II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor Accural
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
Collaborators
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Quality of Life, Neurocognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell Radiotherapy and Temozolomide
Arm Type
Experimental
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
Stem Cell Radiotherapy (ScRT) and Temozolomide
Other Intervention Name(s)
Intensity Modulated Radiation Therapy (IMRT), Temozolomide, Stem Cell Radiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Overall Survival
Description
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).
Time Frame
12 months
Title
Progression-free Survival
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
The short-and long-term toxicity of ScRT (and compare to historical controls).
Time Frame
36 months
Title
Neurocognition
Description
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).
Time Frame
36 month
Title
Quality of Life
Description
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.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Shapira, MD
Organizational Affiliation
St. Luke's - Roosevelt Hospitals& Beth Israel Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahul Parikh, MD
Organizational Affiliation
Roosevelt Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.wehealny.org/services/cancer/studies/index.html
Description
Clinical Trials

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Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma

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