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

  • Italy
      • Rome, Italy, 00144
        • Regina Elena National Cancer Institute

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

Regina Elena Cancer Institute

Collaborators

Valeria Landoni
Diana Giannarelli
Giuseppe Sanguineti
Silvia Takanen
Serena Nucciarelli
Francesco Rulli
Maria Papale
Mauro Caterino
Ilaria Farina
Paola Franzoso

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

Keywords

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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