HIPOMAMMLINF: Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Sponsor

Regina Elena Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04792346

Collaborator

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

Enrollment

Location

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: breast/chest wall radiotherapy

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 Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 7, 2019

Actual Study Completion Date :

Mar 2, 2021

Outcome Measures

Primary Outcome Measures

acute toxicity assessment [60 months]
rate of acute toxicity according to CTCAE v4.0 scale

Secondary Outcome Measures

to evaluate late toxicity [60 months]
rate of late to according to soma lent scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regina Elena National Cancer Institute	Rome		Italy	00144

Investigators

Principal Investigator: Paola Pinnaro, IFO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paola Pinnaro, Doctor, Regina Elena Cancer Institute

ClinicalTrials.gov Identifier:

NCT04792346

Other Study ID Numbers:

RS618/14(1611)

First Posted:

Mar 10, 2021

Last Update Posted:

Mar 10, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paola Pinnaro, Doctor, Regina Elena Cancer Institute

hypofractionated RT

cosmetic outcome

locoregional treatment

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Mar 10, 2021