- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792346
Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer (HIPOMAMMLINF)
March 9, 2021 updated by: Paola Pinnaro, Regina Elena Cancer Institute
a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery
Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery.
Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected.
All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard.
Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rome, Italy, 00144
- Regina Elena National Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The study population included breast cancer patients with nodal involvement who underwent conservative surgery or mastectomy, followed by post operative locoregional radiotherapy after conservative surgery or mastectomy.
Description
Inclusion Criteria:
- Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes.
- pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed;
- ECOG Performance status ≤2;
- histologically negative surgical margins
- no distant metastases
- no prior chest radiotherapy
- life expectancy ≥ 5 years
- no prior cancer
Exclusion Criteria:
- Non-epithelial breast cancer (sarcoma, lymphoma etc.)
- Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed
- pT4 neoplasms or inflammatory breast carcinoma
- Distant metastasis
- Concomitant chemotherapy
- history of prior controlateral breast tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute toxicity assessment
Time Frame: 60 months
|
rate of acute toxicity according to CTCAE v4.0 scale
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to evaluate late toxicity
Time Frame: 60 months
|
rate of late to according to soma lent scale
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paola Pinnaro, IFO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
January 7, 2019
Study Completion (Actual)
March 2, 2021
Study Registration Dates
First Submitted
March 2, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Actual)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RS618/14(1611)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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