Advertisement

Topics

Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

2014-07-23 21:35:20 | BioPortfolio

Summary

The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.

Description

The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM undergoing initial surgical resection will be candidates for this study. Eligible patients will undergo surgical resection within 30 days of diagnosis.

Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed into the tumor cavity.

After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy with the GliaSite® and continued for a total of 7 days.

Within 21 days following radiation therapy with the GliaSite®, external beam radiation therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d) will start on day 1 of external beam radiation therapy and continue through the external beam radiation therapy interval, ending with the last day of radiation.

Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide (150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle.

At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and vomiting).

This will continue for up to a total of 12 cycles, unless disease progression or severe myelosuppression is noted.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma Multiforme

Intervention

temozolomide, Brachytherapy, External Beam Radiation Therapy

Location

Methodist University Hospital
Memphis
Tennessee
United States
38104

Status

Terminated

Source

Methodist Healthcare

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:20-0400

Clinical Trials [2833 Associated Clinical Trials listed on BioPortfolio]

Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide follow...

Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It ...

Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme

The mechanism of action of sorafenib makes it an interesting drug to investigate in the treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic activit...

Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as...

Disulfiram in Treating Patients With Glioblastoma Multiforme After Radiation Therapy With Temozolomide

This clinical trial studies disulfiram in treating patients with glioblastoma multiforme (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of the enzy...

PubMed Articles [13390 Associated PubMed Articles listed on BioPortfolio]

Predictive factors of long-term rectal toxicity following permanent iodine-125 prostate brachytherapy with or without supplemental external beam radiation therapy in 2216 patients.

We analyzed factors associated with rectal toxicity after iodine-125 prostate brachytherapy (BT) with or without external beam radiation therapy (EBRT).

Predicting erectile function following external beam radiation therapy or brachytherapy for prostate cancer using EPIC-CP.

Outcomes and Toxicities in Intermediate-Risk Prostate Cancer Patients Treated with Brachytherapy Alone or Brachytherapy and Supplemental External Beam Radiation Therapy.

To evaluate the cancer control outcomes and long-term treatment-related morbidity of brachytherapy as well as combination brachytherapy and EBRT in patients with intermediate-risk prostate cancer.

Does an Algorithmic Approach to Using Brachytherapy and External Beam Radiation Result in Good Function, Local Control Rates, and Low Morbidity in Patients With Extremity Soft Tissue Sarcoma?

High-dose-rate brachytherapy (HDR-BT) and external-beam radiation therapy (EBRT) are two modalities used in the treatment of soft tissue sarcoma. Previous work at our institution showed early complica...

A comparison of early prostate-specific antigen decline between prostate brachytherapy and different fractionation of external beam radiation-Impact on biochemical failure.

The aim of this study was to compare early prostate-specific antigen (PSA) decline patterns and PSA nadirs between low-dose-rate seed prostate brachytherapy (LDR-PB) and different fractionations of ex...

Medical and Biotech [MESH] Definitions

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

The use of an external beam of PROTONS as radiotherapy.

An optical source that emits photons in a coherent beam. Light Amplification by Stimulated Emission of Radiation (LASER) is brought about using devices that transform light of varying frequencies into a single intense, nearly nondivergent beam of monochromatic radiation. Lasers operate in the infrared, visible, ultraviolet, or X-ray regions of the spectrum.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.

More From BioPortfolio on "Radiation Boost for Newly Diagnosed Glioblastoma Multiforme"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial