LymphedemaNCT02308488
Study of Prone Accelerated Breast And Nodal IMRT
A study testing Intensity-modulated radiation therapy (IMRT) in people with Lymphedema, run by NYU Langone Health at 1 site in United States.
Trial summary
Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3… Read more about this study
- Who is it for?
- Ages 36 to 90 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Intensity-modulated radiation therapy (IMRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 36 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre- or post-menopausal women with stage II - III breast cancer (AJCC 2002)
- Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
- Status post segmental mastectomy or mastectomy and axillary node dissection with removal of at least 8 nodes
- One to 5 involved lymph nodes identified at axillary staging
- At least 2 weeks from last chemotherapy or before chemotherapy
- No more than sixty days from final surgery to simulation if no systemic therapy (includes chemotherapy and Hormonal therapy) is given
- Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
Who cannot join
- Previous radiation therapy to the ipsilateral breast
- More than 5 involved nodes identified at axillary staging
- Current treatment for active connective tissue disorders, such as lupus or scleroderma
- Pregnant or lactating women
- Less than 35 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Laura and Issac Perlmutter Cancer Center
New York, New York, 10016
About this study
Official title: PHASE I - II STUDY OF PRONE ACCELERATED BREAST AND NODAL IMRT(Intensity-Modulated Radiation Therapy)
Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after completion of radiotherapy. All patients will be followed for toxicity and outcome (local and systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.
Read the detailed description
A recent Cochrane Collaboration Intervention Review has addressed the effects of altered fractionation size on women with early breast cancer who have undergone breast conservation surgery. Analysis of two prospective randomized trials that included 2644 women, selected based on tumor size less than five cm, negative pathological margin of excision and negative lymph nodes. No difference in clinical outcome was detected. The conclusion of the review is that the use of unconventional fractionation regimens (greater than 2 Gy per fraction) does not affect breast appearance or toxicity, and does not seem to affect local recurrence or five years survival rates.
After breast surgery and an adequate axillary dissection (i.e., at least 8 nodes retrieved in the axillary dissection specimen from level I and II) it is possible to identify patients with 1 - 5 positive nodes who require radiotherapy to both the indexed breast/chest wall and the draining nodal stations that the surgeon did not include in the traditional level I - II axillary dissection, i.e., level III and supraclavicular stations. We are proposing to test a new technique that extends prone set up to also include these lymph node regions. Limiting treatment to the supraclavicular fossa and level III axilla in patients with an adequately dissected axilla is supported by several published studies. Regional nodal recurrences are rare (occurring in 1 - 5%) in patients with early stage invasive breast cancer who have undergone breast conserving therapy. Several institutions choose to treat only the level III axilla and supraclavicular nodal stations in patients who have undergone surgical treatment of level I/II axilla. This technique was documented recently by Liengsawangwong, who utilized CT-delineated nodal stations to improve target coverage of SCV (Supra-Clavicular) and level III axillary nodes in patients who had undergone axillary level I/II dissection and were found to have positive lymph nodes.
- Conditions
- Lymphedema
- Being tested
- Intensity-modulated radiation therapy (IMRT)
- Keywords
- prone IMRT to breast, level III & Supraclavicular, acute toxicity of prone IMRT to breast, level III & SCV
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiation therapy (IMRT)Radiation
Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | Not described Receives: Radiation: Intensity-modulated radiation therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment
"Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details.
Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death"
Measured: Day 60
Number of Participants Who Met Constraints
Treatment feasibility will be evaluated for each participant by the ability to meet all physics dose constraints:
Target volume dose constraints = PTVTumor: V 48 Gy > 98%, PTVBreast: V 40.5 Gy ≥ 95%. PTVNodesEval: V 38.5 Gy > 95%.
Normal tissue dose constraints = Heart: V 5 Gy < 5%, Ipsilateral lung: V 10 Gy < 20%, Contralateral lung: V 5 Gy < 15%, Spinal cord: 37.5 Gy maximum, Spinal cord plus 0.5 cm margin: 40 Gy maximum, Thyroid: contralateral lobe 15 Gy maximum, Esophagus: V 30 Gy < 50%, 40.5 Gy maximum, Ipsilateral brachial plexus: 42 Gy maximum, Contralateral breast: Efforts should be made to keep the contralateral breast completely outside the primary beams
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2009
- Primary completion17 Sep 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Perez, M.D., Principal investigator, NYU Laura and Issac Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308488
- Sponsor's protocol ID
- 09-0623
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2014
- Last updated
- 27 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I - II STUDY OF PRONE ACCELERATED BREAST AND NODAL IMRT(Intensity-Modulated Radiation Therapy)
- ClinicalTrials.gov ID
- NCT02308488
- Acronym / sponsor ID
- 09-0623
- Conditions
- Lymphedema
- Keywords
- prone IMRT to breast, level III & Supraclavicular, acute toxicity of prone IMRT to breast, level III & SCV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 2 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after completion of radiotherapy. All patients will be followed for toxicity and outcome (local and systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.
Detailed description
A recent Cochrane Collaboration Intervention Review has addressed the effects of altered fractionation size on women with early breast cancer who have undergone breast conservation surgery. Analysis of two prospective randomized trials that included 2644 women, selected based on tumor size less than five cm, negative pathological margin of excision and negative lymph nodes. No difference in clinical outcome was detected. The conclusion of the review is that the use of unconventional fractionation regimens (greater than 2 Gy per fraction) does not affect breast appearance or toxicity, and does not seem to affect local recurrence or five years survival rates.
After breast surgery and an adequate axillary dissection (i.e., at least 8 nodes retrieved in the axillary dissection specimen from level I and II) it is possible to identify patients with 1 - 5 positive nodes who require radiotherapy to both the indexed breast/chest wall and the draining nodal stations that the surgeon did not include in the traditional level I - II axillary dissection, i.e., level III and supraclavicular stations. We are proposing to test a new technique that extends prone set up to also include these lymph node regions. Limiting treatment to the supraclavicular fossa and level III axilla in patients with an adequately dissected axilla is supported by several published studies. Regional nodal recurrences are rare (occurring in 1 - 5%) in patients with early stage invasive breast cancer who have undergone breast conserving therapy. Several institutions choose to treat only the level III axilla and supraclavicular nodal stations in patients who have undergone surgical treatment of level I/II axilla. This technique was documented recently by Liengsawangwong, who utilized CT-delineated nodal stations to improve target coverage of SCV (Supra-Clavicular) and level III axillary nodes in patients who had undergone axillary level I/II dissection and were found to have positive lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Intensity-modulated radiation therapy (IMRT) |
Who may qualify
- Ages
- 36 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pre- or post-menopausal women with stage II - III breast cancer (AJCC 2002)
- Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
- Status post segmental mastectomy or mastectomy and axillary node dissection with removal of at least 8 nodes
- One to 5 involved lymph nodes identified at axillary staging
- At least 2 weeks from last chemotherapy or before chemotherapy
Key exclusion criteria (5 listed)
- Previous radiation therapy to the ipsilateral breast
- More than 5 involved nodes identified at axillary staging
- Current treatment for active connective tissue disorders, such as lupus or scleroderma
- Pregnant or lactating women
- Less than 35 years old
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 |
|---|---|---|
| Intensity-modulated radiation therapy (IMRT)Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed. | Radiation | Radiation Therapy |
Primary outcome
Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment
Time frame: Day 60
"Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details. Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death"
Number of Participants Who Met Constraints
Time frame: Day 60
Treatment feasibility will be evaluated for each participant by the ability to meet all physics dose constraints: Target volume dose constraints = PTVTumor: V 48 Gy > 98%, PTVBreast: V 40.5 Gy ≥ 95%. PTVNodesEval: V 38.5 Gy > 95%. Normal tissue dose constraints = Heart: V 5 Gy < 5%, Ipsilateral lung: V 10 Gy < 20%, Contralateral lung: V 5 Gy < 15%, Spinal cord: 37.5 Gy maximum, Spinal cord plus 0.5 cm margin: 40 Gy maximum, Thyroid: contralateral lobe 15 Gy maximum, Esophagus: V 30 Gy < 50%, 40.5 Gy maximum, Ipsilateral brachial plexus: 42 Gy maximum, Contralateral breast: Efforts should be made to keep the contralateral breast completely outside the primary beams
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
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. This study is not recruiting at the moment.
Carmen Perez, M.D. principal investigator
NYU Laura and Issac Perlmutter Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity-modulated radiation therapy (IMRT) in people with Lymphedema, run by NYU Langone Health at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 27 Apr 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment (time frame: Day 60). The study lists 2 primary outcomes in all. 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 27 Apr 2023.