NCT03121248Active, not recruiting
Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years
A Partially Randomized Patient Preference Trial, Comparing Adjuvant Hypofractionated Radiotherapy in 15 Versus 5 Fractions After Breast Conserving Surgery or Mastectomy for Early or Locally Advanced Breast Cancer in Women Above 65 Years
Source: ClinicalTrials.gov · Last updated 22 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 13 Jan 2017
- Start date
- 15 Feb 2017
- Primary completion date
- 15 Nov 2021
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03121248
What you commit to
- Study type: Interventional
- Participants enrolled: 144
- From 15 Feb 2017 to the primary completion date, 15 Nov 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous radiation treatment to the same region
- Bilateral breast irradiation
- Planned reconstructive breast surgery
Other illness
- Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, …
- Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Other
- Life expectancy of less than 2 years
- Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study
Who the study is looking for
- breast conserving surgery or mastectomy for breast carcinoma
- multidisciplinary decision of adjuvant irradiation
- absence of distant metastases
- informed consent obtained, signed and dated before specific protocol procedures
Age in the registry: 65 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent University Hospital, Dept. Radiotherapy-Oncology Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.