Image-derived Prediction of Response to Chemo-radiation in Glioblastoma

NCT02329795 | Terminated DMC

• 1 other identifier: 192/13
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and radiation treatment.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of predicted response

  Tumor response is measured as contrast-enhancing tumor on T1-weighted MRI and by metabolic active tumor using 18F-fluroethyl-tyrosine (FET)-PET. Pre-treatment risk map is constructed using machine learning methods and compared to post-treatment scans.

  3 months post radiotherapy

Secondary Outcomes (2)

• DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI

  3 months post radiotherapy

• Correlation (volume and maximum values) between lactate and hypoxia

  1 week before start of chemoradiotherapy

Study Arms (1)

Standard chemoradiotherapy

Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.

Radiation: Radiotherapy; Drug: Temozolomide

Interventions

Radiotherapy RADIATION

60 Gy in 30 fractions, 5 days a week, modulated arc therapy.

Standard chemoradiotherapy

Temozolomide DRUG

Concomitant: 75 mg/m2 5 days a week from start of radiotherapy. Adjuvant: 150/200 mg/m2 in 5 days per 28 days in 6 months.

Also known as: Temodar

Standard chemoradiotherapy

Eligibility Criteria

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

Study Population

Patients with primary glioblastoma, eligible for chemoradiotherapy.

You may qualify if:

• Histologically confirmed, primary supratentorial glioblastoma (WHO grade IV).

You may not qualify if:

• No informed consent can be obtained
• Inability to undergo MRI examination, due to metal implants, pacemaker etc.
• Not eligible for Stupp-regimen

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Oncology, Section for Radiotherapy, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d.-fellow, M.Sc.

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 1, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

DK (1)