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Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme

2015-04-02 08:23:23 | BioPortfolio

Summary

This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection.

This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).

Description

This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by:

- Age (<65 and ≥65 years old)

- Karnofsky Performance Status (≤70 and > 7050 or higher)

- Extent of the resection at surgery (biopsy only versus complete/near total and gross total or incomplete /partial resection)

Randomization:

Patients will be randomized to receive one of the two following treatments:

Arm 1:

- Short Radiotherapy

- 25 Gy/5 fractions

- 1 week (5 fractions per week)

Arm 2:

- Regular Radiotherapy

- 40 Gy/15 fractions

- 3 weeks (5 fractions per week)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma Multiforme

Intervention

Radiotherapy, Radiotherapy

Location

Fundacion Escuela de Medicina Nuclear
Mendoza
Argentina
5500

Status

Completed

Source

International Atomic Energy Agency

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-02T08:23:23-0400

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Medical and Biotech [MESH] Definitions

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

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Radiotherapy where cytotoxic radionuclides are linked to antibodies in order to deliver toxins directly to tumor targets. Therapy with targeted radiation rather than antibody-targeted toxins (IMMUNOTOXINS) has the advantage that adjacent tumor cells, which lack the appropriate antigenic determinants, can be destroyed by radiation cross-fire. Radioimmunotherapy is sometimes called targeted radiotherapy, but this latter term can also refer to radionuclides linked to non-immune molecules (see RADIOTHERAPY).

Computer-assisted mathematical calculations of beam angles, intensities of radiation, and duration of irradiation in radiotherapy.

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