NCT02039778

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed
Last Updated

June 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

January 16, 2014

Results QC Date

January 25, 2017

Last Update Submit

April 28, 2017

Conditions

GlioblastomaMalignant GliomaBrain TumorsAnaplastic Astrocytoma

Keywords

GlioblastomaHigh-grade GliomaBrain TumsTemozolomideStem cell radiation therapyIMRTProton beam radiotherapyConventional external beam radiotherapyQuality of LifeNeurocognition

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    12 months

Secondary Outcomes (3)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    36 months

  • Neurocognition

    36 month

  • Quality of Life

    36 months

Study Arms (1)

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).

Radiation: Stem Cell Radiotherapy (ScRT) and Temozolomide

Interventions

Stem Cell Radiotherapy (ScRT) and TemozolomideRADIATION

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).

Also known as: Intensity Modulated Radiation Therapy (IMRT), Temozolomide, Stem Cell Radiotherapy
Stem Cell Radiotherapy and Temozolomide

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roosevelt Hospital

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

GlioblastomaGliomaBrain NeoplasmsAstrocytoma

Interventions

TemozolomideRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title
Dr. Rahul Parikh
Organization
Mount Sinai Beth Israel
parikhrr@cinj.rutgers.edu
732-253-3939

Study Officials

  • Ilan Shapira, MD

    St. Luke's - Roosevelt Hospitals& Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

  • Rahul Parikh, MD

    Roosevelt Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 5, 2017

Results First Posted

June 5, 2017

Record last verified: 2017-04

Locations

US(1)