Advertisement

Topics

Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years

2017-04-21 07:08:22 | BioPortfolio

Summary

This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer.

Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.

Description

Over the age of 65, uptake of adjuvant radiotherapy after surgery for breast cancer declines, even in women with poor prognostic stage or adverse tumor characteristics.

Lowering the number of fractions may reduce reluctancy for radiotherapy in this age group.

In a preceding prospective phase I-II trial, evaluating EBRT over 10 days, results on technical feasibility and acute toxicity were positively evaluated.

However, data on the chronic effects of breast irradiation using high doses per fraction are still sparse.

This trial is developed to compare standard hypo-fractionation in 15 fractions (if needed with simultaneously integrated boost - SIB) with highly accelerated radiotherapy in 5 fractions.

Patients referred for adjuvant radiotherapy after breast conserving surgery will preferably be randomized, depending on the indication, to a study-arm with whole breast irradiation (WBI) +/- SIB or to a study-arm with WBI+/- SIB and lymph node irradiation (LNI).

If patients after breast conserving surgery (BCS) have a strong preference for 5 or 15 fractions, they will be invited to enter the parallel observational arm (patient preference).

Patients referred for adjuvant radiotherapy after mastectomy +/- LNI accepting to participate, can choose a 5 or 15-fraction schedule. No randomization is foreseen in this last observational group.

Study Design

Conditions

Breastcancer

Intervention

WBI 5 fractions, WBI 15 fractions, LNI 5 fractions, LNI 15 fractions, SIB 5 fractions if needed, SIB 15 fractions if needed, TWI 5 fractions, TWI 15 fractions

Location

Ghent University Hospital, Dept. Radiotherapy-Oncology
Ghent
Belgium
9000

Status

Recruiting

Source

University Hospital, Ghent

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-04-21T07:08:22-0400

Clinical Trials [1031 Associated Clinical Trials listed on BioPortfolio]

5 Fractions of Pelvic SABR With Intra Prostatic SABR

Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once...

APBI: 27Gy in 5 Fractions for Early Breast Cancer

This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is expected to be equally tolerated as standard whole breast irradiation (WBI) based on radiobiol...

PROFIT - Prostate Fractionated Irradiation Trial

This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.

Feasibility Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative RT in Spinal Metastases

The purpose of this study is to obtain preliminary information that will help, in the future, design a large trial, to see if SBRT is better than CRT at controlling pain in the spine.

Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.

The aim of the investigators study was to determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painf...

PubMed Articles [4521 Associated PubMed Articles listed on BioPortfolio]

Characterization and Phenanthrene Sorption of Natural and Pyrogenic Organic Matter Fractions.

Pyrogenic humic acid (HA) is released into the environment during the large-scale application of biochar. However, the biogeochemistry of pyrogenic organic matter (PyOM) fractions and their sorption o...

Variations in the composition of house dust by particle size.

In this study, the distribution of heavy metals and other components in the various size fractions of house dust is investigated. A house dust sample collected from a vacuum cleaner was separated into...

Raman spectroscopy for the characterization of different fractions of hemp essential oil extracted at 130°C using steam distillation method.

In this study, Raman spectroscopy along with Principal Component Analysis (PCA) is used for the characterization of pure essential oil (pure EO) isolated from the leaves of the Hemp (Cannabis sativa L...

Remediation of soil contaminated with organic and inorganic wood impregnation chemicals by soil washing.

The aim of this study was to evaluate the efficiency of a large scale washing/wet sieving technique for a soil contaminated with wood impregnation chemicals by 1) defining the final distribution of tr...

Characterizing differences in the phosphorus activation coefficient of three typical cropland soils and the influencing factors under long-term fertilization.

The phosphorus activation coefficient (PAC, the ratio of available P to total P) is an important indicator of soil P availability and the transformation of P fractions. Understanding the details of th...

Medical and Biotech [MESH] Definitions

Heparin fractions with a molecular weight usually between 4000 and 6000 kD. These low-molecular-weight fractions are effective antithrombotic agents. Their administration reduces the risk of hemorrhage, they have a longer half-life, and their platelet interactions are reduced in comparison to unfractionated heparin. They also provide an effective prophylaxis against postoperative major pulmonary embolism.

An ester of nicotinic acid that lowers cholesterol and triglycerides in total plasma and in the VLD- and LD-lipoprotein fractions.

Techniques to partition various components of the cell into SUBCELLULAR FRACTIONS.

Simple protein, one of the prolamines, derived from the gluten of wheat, rye, etc. May be separated into 4 discrete electrophoretic fractions. It is the toxic factor associated with CELIAC DISEASE.

Venoms of arthropods of the order Araneida of the ARACHNIDA. The venoms usually contain several protein fractions, including ENZYMES, hemolytic, neurolytic, and other TOXINS, BIOLOGICAL.

More From BioPortfolio on "Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years"

Quick Search
Advertisement
 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial