Lymphedema Evaluation After Adjuvant Hypofractionated Rad... | NCT06321653

Studies
Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

NCT06321653

Sponsor

European Institute of Oncology

Status

Recruiting

Last Update Posted

Mar 20, 2024Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Arm Lymphedema
Breast Cancer
Radiotherapy Side Effect

Interventions

Hypofractionated radiotherapy scheme

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 19, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections.

Detailed Description

In recent years, breast oncologic surgery has aimed to omit axillary dissection in cases where no more than two sentinel lymph nodes are positive, particularly when complementary radiotherapy to the whole breast is planned.

Radiation therapy to the axillary lymph nodes ensures excellent locoregional control in patients with primary tumor no more than 5 centimeter and 1-2 macrometastatic sentinel lymph nodes, and appears to carry fewer side effects than axillary dissection.

Arm lymphedema is indeed one of the most well-known long-term complications of breast cancer treatment, impacting the quality of life for patients undergoing lymphadenectomy. In this scenario, the study proposes a treatment of hypofractionated intensity-modulated radiotherapy (IMRT) to the breast and axillary lymph nodes with the aim of further containing the risk of developing ipsilateral arm lymphedema. IMRT improves the dosimetric profile of surrounding organs at risk in the treated area, with better dose conformity to the target volume compared to tangential fields used in conventional 3D conformal techniques (as employed in most trials described so far).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypofractionated radiotherapy		Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed	Radiation: Hypofractionated radiotherapy scheme

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypofractionated radiotherapy scheme	Radiation	Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with arm lymphedema	Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy	1 year

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of cute locoregional toxicity at breast and axilla	During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale	6 months
Evaluation of chronic toxicity at breast and axilla

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological proven invasive breast cancer
Breast conserving surgery with no axillary dissection
Tumor dimension no more then 5 cm and no more than 2 positive sentinel node

5) Negative surgical margin (no tumor cell on ink) 6) Performance Status (PS) <2 7) Age >18 8) Written informed consent

Exclusion Criteria:

Previous thoracic RT
Mixed connective disorders
Distant metastases
Severe lung or cardiac diseases
Neoadjuvant systemic therapies
Axillary dissection
No surgical axillary investigation
Mastectomy
Axillary micrometastasis or isolated tumor cell

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with invasive breast cancer staged clinically node negative and no more then 5 cm of breast tumor, scheduled for quadrantectomy and SNB, are enrolled in the protocol if they have 1-2 SLNs with macrometastases. SLN status will be checked on definitive sections

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Cristina Leonardi, MD	Contact	+39 02 94372156		cristina.leonardi@ieo.it

Overall Officials

Name	Affiliation	Role
Maria Cristina Leonardi, MD	European Institute of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
European Institute of Oncology	Recruiting	Milan			Italy

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D011832	Radiation Injuries

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

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