A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma

NCT02805179 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2012.006HUM00113549
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT) with concurrent temozolomide in patients with newly diagnosed glioblastoma.

Conditions

Glioma

Outcome Measures

Primary Outcomes (2)

• Overall Survival at 12 Months

  Percentage of patients alive at 12 months after completion of chemoradiation

  12 months after completion of chemoradiation

• Median Overall Survival

  Median overall survival in months

  Median follow-up time was 26 months

Secondary Outcomes (4)

• Median Progression-free Survival

  Median follow-up time was 26 months

• Median Change in Tumor Volume From Baseline to Mid-radiation Treatment (Week 4)

  Baseline to Week 4

• Percentage of Patients That Experienced Deterioration in Quality of Life (QOL)

  Baseline to 1 and 7 months

• Percentage of Patients With Failure; Central or In-field vs. Marginal or Distant

  Median 26 months

Study Arms (1)

High Dose Chemoradiation

EXPERIMENTAL

Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide.

Radiation: High Dose Radiation; Drug: Temozolomide

Interventions

High Dose Radiation RADIATION

Radiation will be delivered once daily for a total of 30 fractions, five days per week.

High Dose Chemoradiation

Temozolomide DRUG

Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.

High Dose Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed histologically-confirmed supratentorial World Health Organization (WHO) grade IV gliomas including glioblastoma multiforme and gliosarcoma
• Age 18 or older
• Karnofsky performance status (a measure to quantify general well being and activities of daily life; scale ranges from 0 to 100 where 100 is perfect health) of greater than or equal to 70
• Life expectancy of at least 12 weeks
• Adequate bone marrow reserve (hemoglobin greater than or equal to 10, absolute neutrophil count greater than or equal to 1500, platelets greater than or equal to 100,000); acceptable liver function (total bilirubin less than or equal to 2.0 mg/dl, ALT (Alanine Aminotransferase)/AST (Aspartate Aminotransferase) less than or equal to 5 times the normal range); acceptable renal function (serum creatinine less than or equal to 2.0 mg/dl). Eligibility level for hemoglobin may be reached by transfusion.
• Maximal contiguous volume of tumor based on high b-value diffusion MRI \< 1/3 volume of brain
• Patients must be registered within 6 weeks of most recent resection.
• Patients must have signed a study-specific informed consent.

You may not qualify if:

• Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
• Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable, except for Temozolomide or Bevacizumab.
• Evidence of cerebrospinal fluid dissemination (positive cerebrospinal fluid cytology for malignancy or MRI findings consistent with CSF dissemination)
• Evidence of severe concurrent disease requiring treatment
• Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)
• Patients unable to undergo Magnetic Resonance Imaging exams (MRI) (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips) or unable to receive gadolinium for MRI, as per the standard UM Department of Radiology MRI screening criteria)
• Patients treated with previous cranial or head/neck radiotherapy leading to radiation field overlap
• Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Lee SW, Fraass BA, Marsh LH, Herbort K, Gebarski SS, Martel MK, Radany EH, Lichter AS, Sandler HM. Patterns of failure following high-dose 3-D conformal radiotherapy for high-grade astrocytomas: a quantitative dosimetric study. Int J Radiat Oncol Biol Phys. 1999 Jan 1;43(1):79-88. doi: 10.1016/s0360-3016(98)00266-1.

  PMID: 9989517 RESULT

MeSH Terms

Conditions

Glioma

Interventions

Radiation; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michelle Kim, MD
• Organization: University of Michigan

michekim@med.umich.edu

734-936-4300

Study Officials

• Michelle Kim, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 17, 2016
• Study Start: September 22, 2016
• Primary Completion: February 6, 2020
• Study Completion: November 18, 2020
• Last Updated: April 15, 2021
• Results First Posted: April 15, 2021

Record last verified: 2021-03

Locations

US (1)