Arm LymphedemaAXILL-ARTNCT06321653
Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes
An observational study of Arm Lymphedema and Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arm Lymphedema, Breast Cancer, Radiotherapy Side Effect
- What is being tested?
- Hypofractionated radiotherapy scheme
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Previous thoracic RT
- Mixed connective disorders
- Distant metastases
- Severe lung or cardiac diseases
- Neoadjuvant systemic therapies
- Axillary dissection
Show all 9Show fewer
- No surgical axillary investigation
- Mastectomy
- Axillary micrometastasis or isolated tumor cell
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Maria Cristina Leonardi, +39 02 94372156
About this study
Official title: AXILL-ART: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes Without Axillary Dissection in Breast Cancer Conservative Surgery: Observational Study
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.
Read the 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).
- Conditions
- Arm Lymphedema, Breast Cancer, Radiotherapy Side Effect
- Being tested
- Hypofractionated radiotherapy scheme
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapy schemeRadiation
Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy | Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed Receives: Radiation: Hypofractionated radiotherapy scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with arm lymphedema
Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy
Measured: 1 year
Secondary outcomes (5)
Evaluation of cute locoregional toxicity at breast and axilla
During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale
Measured: 6 months
Evaluation of chronic toxicity at breast and axilla
Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward
Measured: 5 years
Disease free survival
Number of patients with an oncological event (local, regional and distant recurrence free survival)
Measured: 5 years
Overall survival
Number of patient alive after 5 years of follow up
Measured: 5 years
Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla
Numeric Rating Scale (NRS) (NRS-11) is an 11-point scale for patient self-reporting of pain. It is used for rating symptoms like pain, itching and burning
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start18 Apr 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arm LymphedemaStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cristina Leonardi, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321653
- Sponsor's protocol ID
- IEO 0953
- Acronym
- AXILL-ART
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXILL-ART: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes Without Axillary Dissection in Breast Cancer Conservative Surgery: Observational Study
- ClinicalTrials.gov ID
- NCT06321653
- Acronym / sponsor ID
- AXILL-ART / IEO 0953
- Conditions
- Arm Lymphedema, Breast Cancer, Radiotherapy Side Effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy | – | Radiation: Hypofractionated radiotherapy schemeHypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Previous thoracic RT
- Mixed connective disorders
- Distant metastases
- Severe lung or cardiac diseases
- Neoadjuvant systemic therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapy schemeHypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed | Radiation | Hypofractionated radiotherapy |
Primary outcome
Percentage of patients with arm lymphedema
Time frame: 1 year
Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy
5 secondary outcomes
Evaluation of cute locoregional toxicity at breast and axilla
Time frame: 6 months
Evaluation of chronic toxicity at breast and axilla
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Cristina Leonardi, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arm Lymphedema and Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Cristina Leonardi, MD (+39 02 94372156, cristina.leonardi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with arm lymphedema (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.