Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment

Helical tomotherapy IMRT

Jean-Michel Caudrelier, md

Research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage IIB-III breast cancer. The current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage IIb-III breast cancer.

The role of locoregional radiation therapy in the management of stage IIB and III breast cancer has evolved and continues to evolve. The exact role of locoregional radiation, including axillary, supraclavicular and internal mammary nodes is, however, not clear. Radiation-induced toxicity remains a limiting factor to expanding the indications for radiation therapy to axillary and internal mammary nodes in the treatment of stage IIB and III breast cancer. Excellent target coverage and normal tissue sparing of IMRT has been previously demonstrated dosimetrically and clinically. In this feasibility study, patients will receive 50 Gy of radiation therapy in 25 fractions to the chest wall and supraclavicular, axillary and IM nodal areas using HT-IMRT following breast conserving surgery or mastectomy and chemotherapy. Patients will also be eligible for a radiation boost to 12 Gy by HT-IMRT or HDR brachytherapy. It is expected that treatment with HT-IMRT will result in appreciably fewer side-effects following locoregional irradiation due to a reduction in normal tissue irradiation, as compared to conventional radiation therapy.

Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer

Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study

Evaluate acute radiation effects(less than 90 days post treatment)

Evaluate moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation

Evaluate rate of local recurrence at 5 years

Evaluate rate of regional recurrence at 5 years

Ottawa Hospital Research Institute

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Conventional fractionation for locoregional radiotherapy

Hypofractionation for locoregional radiotherapy

40 Gray in 15 daily fractions over 3 weeks

Locoregional radiation treatment - Conventional fractionation

Locoregional radiation treatment - Hypofractionation

Brittany Speller

Sharon Nason

Marny Yar

Jeff Cao

Juliette Jordan

Fleur Huang

Kiana Wong

Angela Lin

Ketki Merchant

Alan Nichol

Lily Hallett Rio

Tanya Berrang

Brenda DeMedeiros

Tim Whelan

Alisha Moynahan

Francisco Perera

Krista Liimatainen

Lynn Chang

Amanda Snyder

Jacqueline Lam

Clarissa Chau

Eileen Rakovitch

Vicky Gillman

Kathy Han

Pierre Bedard

Anne Dagnault

Lys Fernet

Michael Yassa, MD

Marianna Perna

Tarek Hijal

Mom Phat

Pierre Rousseau

Josee Allard

Valerie Theberge

Bernadette Procyk

Derek Suderman

Shavaun Liss

Philip Wright

Timothy Whelan

The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.

A multi-centre, randomized, non-inferior, phase III study comparing two radiation treatment modalities, conventional fractionation with hypofractionation for locoregional RT. Eligible, consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast without evidence of metastatic disease; treated with definitive surgery \[BCS or mastectomy with nodal staging using sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)\] will be randomized in a 1:1 fashion to either conventional locoregional RT (control group) or hypofractionated locoregional RT (experimental group). Stratification factors include: body mass index, the performance of ALND, type of surgery (BCS or mastectomy) and clinical centre.

Study participants will be assessed for lymphedema, the primary outcome, by measuring arm volume. Arm mobility will be assessed by measuring arm movement. Study participants will be assessed for acute and late radiation toxicities, during and post RT. Study participants will be followed and assessed annually for breast cancer recurrence (BCR), new second cancers, quality of life (QOL) and overall survival. Cost effectiveness and cost utility will also be determined. The planned sample size is 588 study participants. The study will be conducted at clinical centres throughout Canada.

Hypofractionated LocoRegional Radiotherapy in Breast Cancer

Randomized Trial of Hypofractionated LocoRegional Radiotherapy in Breast Cancer and Lymphedema (RHEAL)

Lymphedema defined as relative volume change (RVC) ≥10%

Both locoregional and distant recurrence and second cancers

Assessed by measuring the straight lateral abduction of both the ipsilateral and contralateral arm

Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Breast Cancer Specific Module 23. The scale is 1 to 4 where a higher score means a worse outcome.

Impact of lymphedema on quality of life will be assessed with the National Surgical Adjuvant Breast and Bowel Project questionnaire. The scale is 1 to 5 where a higher score means a worse outcome.

Patient-reported breast cosmesis using a Breast Cosmesis Questionnaire to study the late effects of radiation.

Health Care Resource Utilization will be estimated using dates and duration of radiotherapy treatment and emergency department visits and hospitalizations.

Patient costs will be assessed using a Time Off Work Questionnaire to study the financial impact of breast cancer and its treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer	NCT00508352	Breast Cancer	Helical tomothe...	18 Years -	Ottawa Hospital Research Institute
Hypofractionated LocoRegional Radiotherapy in Breast Cancer	NCT04228991	Breast Neoplasm... Radiotherapy Lymphedema	Locoregional ra... Locoregional ra...	18 Years -	Ontario Clinical Oncology Group (OCOG)

Spots Global Cancer Trial Database for locoregional

Every month we try and update this database with for locoregional cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.