Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

NCT04792346 | Completed

• 1 other identifier: RS618/14(1611)
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

hypofractionated RT; cosmetic outcome; locoregional treatment

Outcome Measures

Primary Outcomes (1)

• acute toxicity assessment

  rate of acute toxicity according to CTCAE v4.0 scale

  60 months

Secondary Outcomes (1)

• to evaluate late toxicity

  60 months

Interventions

breast/chest wall radiotherapy RADIATION

34 Gy/10 fxs/2 wks to the whole breast/chest wall and locoregional lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients undergoing conservative surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Giuseppe Sanguineti: collaborator
• Silvia Takanen: collaborator
• Serena Nucciarelli: collaborator
• Francesco Rulli: collaborator
• Maria Papale: collaborator
• Valeria Landoni: collaborator
• Mauro Caterino: collaborator
• Diana Giannarelli: collaborator
• Ilaria Farina: collaborator
• Paola Franzoso: collaborator

Study Sites (1)

Regina Elena National Cancer Institute

Rome, 00144, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paola Pinnaro

  IFO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: January 1, 2015
• Primary Completion: January 7, 2019
• Study Completion: March 2, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)