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

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ClinicalTrials.gov Identifier: NCT02039778
Recruitment Status : Terminated (Poor Accural)
First Posted : January 20, 2014
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma
Malignant Glioma
Brain Tumors
Anaplastic Astrocytoma
Intervention Radiation: Stem Cell Radiotherapy (ScRT) and Temozolomide
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Death             2
Withdrawal by Subject             1
Never started the protocol treatment             1
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
1.Primary Outcome
Title Overall Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description:

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
2.Primary Outcome
Title Progression-free Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
no data available due to no subject completed the study. data not collected
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description:

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description The short-and long-term toxicity of ScRT (and compare to historical controls).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description:

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
4.Secondary Outcome
Title Neurocognition
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
no data available due to no subject completed the study. data not collected
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description:

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Quality of Life
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
no data available due to no subject completed the study. data not collected
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description:

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stem Cell Radiotherapy and Temozolomide
Hide Arm/Group Description

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Stem Cell Radiotherapy (ScRT) and Temozolomide

All-Cause Mortality
Stem Cell Radiotherapy and Temozolomide
Affected / at Risk (%)
Total   2/4 (50.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Stem Cell Radiotherapy and Temozolomide
Affected / at Risk (%)
Total   2/4 (50.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death   2/4 (50.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stem Cell Radiotherapy and Temozolomide
Affected / at Risk (%)
Total   4/4 (100.00%) 
Blood and lymphatic system disorders   
Platelet count decreased   1/4 (25.00%) 
Eye disorders   
Blurred vision   1/4 (25.00%) 
General disorders   
Fatigue   1/4 (25.00%) 
Nausea   1/4 (25.00%) 
Headache   1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Dry skin   1/4 (25.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rahul Parikh
Organization: Mount Sinai Beth Israel
Phone: 732-253-3939
EMail: parikhrr@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02039778     History of Changes
Other Study ID Numbers: 13-0151
13-0151 ( Other Identifier: 13-0151 )
First Submitted: January 16, 2014
First Posted: January 20, 2014
Results First Submitted: January 25, 2017
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017