Breast CancerIORT-SeinNCT00556777
Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer
A study testing axillary lymph node dissection, conventional surgery and sentinel lymph node biopsy in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed. Read more about this study
- Who is it for?
- Ages 65 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- axillary lymph node dissection, conventional surgery and sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2004to 31 Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 120 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed stage I breast cancer
- Size ≤ 20 mm (by ultrasound), N0, any quadrant
- Hormone receptor status not specified
Who cannot join
- Distant metastases
- Inflammatory breast cancer
- Lobular in situ disease
- Invasive cancer or ductal carcinoma in situ
- Nonepithelial disease or sarcoma
- Multicentric disease
Show all 19Show fewer
- Lymphatic embolism
- Margins of safety unknown or positive (in situ or invasive)
- Preoperative mammography showing diffuse microcalcification
- PATIENT CHARACTERISTICS:
- Female
- Menopausal
- Karnofsky 70-100%
- No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years
- No geographic, social, or psychiatric reasons that would impede participation in study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior neoadjuvant therapy
- No concurrent participation in another study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
About this study
Official title: Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.
Secondary
- Study the impact of this regimen on maintaining self-care.
- Study the quality of life (QLQ-C30) and satisfaction with care.
- Study regimen tolerance and cosmetic results.
- Evaluate the economic impact of this treatment.
- Study relapse-free and disease-specific survival.
OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast.
Patients may begin hormonal therapy after completing study therapy.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
- Conditions
- Breast Cancer
- Being tested
- axillary lymph node dissection, conventional surgery, sentinel lymph node biopsy, intraoperative radiation therapy
- Keywords
- stage I breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary lymph node dissectionProcedure or surgery
conventional surgeryProcedure or surgery
sentinel lymph node biopsyProcedure or surgery
intraoperative radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | breast conserving surgery with lymph node dissection + Intraoperative radiotherapy Receives: Procedure: axillary lymph node dissection; Procedure: conventional surgery; Procedure: sentinel lymph node biopsy; Radiation: intraoperative radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
feasibility based on dosimetric criteria based on the Quality Index of the application.
Measured: During the treatment of irradiation (4 weeks)
Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
reproducibility based on dosimetric criteria based on the Quality Index of the application.
Measured: During the treatment of irradiation (4 weeks)
Secondary outcomes (5)
impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
Impact described by th scores of "Instrumental Activities of Daily Living scale"
Measured: from the baseline to 12 months after the treatment
impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
Impact described by th scores of "Activities of Daily Living scale"
Measured: from the baseline to 12 months after the treatment
Tolerability of partial irradiation of the breast by per-operative electron therapy
Tolerability done with Common Terminology Criteria for Adverse Events scale
Measured: from the baseline to 12 months after the treatment
Relapse-free survival
Relapse-free survival describes with radiologie evaluation
Measured: from the baseline to 12 months after the treatment
Disease-specific survival
Relapse-free survival describes with radiologie evaluation
Measured: from the baseline to 12 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study start19 Apr 2004
- Primary completion31 Dec 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Model description
- partial irradiation of the breast, after an enlarged tumorectomy and negative sentinel limph node, assessing the feasibility and technical reproducibility of a per-concentrated irradiationThe first treatment was a surgical operation focused on the initial tumor area as the only treatment
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Bernard Dubois, MD, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556777
- Sponsor's protocol ID
- CDR0000574074
- Other IDs
- CLCC-IORT-Sein, INCA-RECF0284
- Acronym
- IORT-Sein
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2007
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aaronson NK. Assessing the quality of life of patients in cancer clinical trials: Common problems and common sense solutions. Eur J Cancer. 1992;28A(8-9):1304-7. doi: 10.1016/0959-8049(92)90504-u. No abstract available.
PubMed 1515238Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Nattinger AB, Kneusel RT, Hoffmann RG, Gilligan MA. Relationship of distance from a radiotherapy facility and initial breast cancer treatment. J Natl Cancer Inst. 2001 Sep 5;93(17):1344-6. doi: 10.1093/jnci/93.17.1344. No abstract available.
PubMed 11535710Arnulf G. Lymphoedema of the upper limb after Halsted's operation of radical mastectomy.. Lymphography and phlebography. Therapeutic consequences. Vasc Surg. 1973 Jan-Feb;7(1):36-44. doi: 10.1177/153857447300700105. No abstract available.
PubMed 4691036Arriagada R, Le MG, Rochard F, Contesso G. Conservative treatment versus mastectomy in early breast cancer: patterns of failure with 15 years of follow-up data. Institut Gustave-Roussy Breast Cancer Group. J Clin Oncol. 1996 May;14(5):1558-64. doi: 10.1200/JCO.1996.14.5.1558.
PubMed 8622072Balducci L, Extermann M, Carreca I. Management of breast cancer in the older woman. Cancer Control. 2001 Sep-Oct;8(5):431-41. doi: 10.1177/107327480100800507.
PubMed 11579340Balducci L, Lyman GH. Cancer in the elderly. Epidemiologic and clinical implications. Clin Geriatr Med. 1997 Feb;13(1):1-14.
PubMed 8995097Ballard-Barbash R, Potosky AL, Harlan LC, Nayfield SG, Kessler LG. Factors associated with surgical and radiation therapy for early stage breast cancer in older women. J Natl Cancer Inst. 1996 Jun 5;88(11):716-26. doi: 10.1093/jnci/88.11.716.
PubMed 8637025Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
PubMed 11794170Bates T, Riley DL, Houghton J, Fallowfield L, Baum M. Breast cancer in elderly women: a Cancer Research Campaign trial comparing treatment with tamoxifen and optimal surgery with tamoxifen alone. The Elderly Breast Cancer Working Party. Br J Surg. 1991 May;78(5):591-4. doi: 10.1002/bjs.1800780523.
PubMed 2059815Brenier JL. The role of the Halsted operation in treatment of breast cancer. Int Surg. 1967 Mar;47(3):288-90. No abstract available.
PubMed 4962239Buchholz TA, Austin-Seymour MM, Moe RE, Ellis GK, Livingston RB, Pelton JG, Griffin TW. Effect of delay in radiation in the combined modality treatment of breast cancer. Int J Radiat Oncol Biol Phys. 1993 Apr 30;26(1):23-35. doi: 10.1016/0360-3016(93)90169-v.
PubMed 8482628Clark RM, Whelan T, Levine M, Roberts R, Willan A, McCulloch P, Lipa M, Wilkinson RH, Mahoney LJ. Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group. J Natl Cancer Inst. 1996 Nov 20;88(22):1659-64. doi: 10.1093/jnci/88.22.1659.
PubMed 8931610Cooke AL, Perera F, Fisher B, Opeitum A, Yu N. Tamoxifen with and without radiation after partial mastectomy in patients with involved nodes. Int J Radiat Oncol Biol Phys. 1995 Feb 15;31(4):777-81. doi: 10.1016/0360-3016(94)00499-4.
PubMed 7860388Diab SG, Elledge RM, Clark GM. Tumor characteristics and clinical outcome of elderly women with breast cancer. J Natl Cancer Inst. 2000 Apr 5;92(7):550-6. doi: 10.1093/jnci/92.7.550.
PubMed 10749910
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00556777
- Acronym / sponsor ID
- IORT-Sein / CDR0000574074
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 19 Apr 2004 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 12 Nov 2007 (estimated)
- 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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.
Detailed description
OBJECTIVES:
Primary
- Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.
Secondary
- Study the impact of this regimen on maintaining self-care.
- Study the quality of life (QLQ-C30) and satisfaction with care.
- Study regimen tolerance and cosmetic results.
- Evaluate the economic impact of this treatment.
- Study relapse-free and disease-specific survival.
OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast.
Patients may begin hormonal therapy after completing study therapy.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- partial irradiation of the breast, after an enlarged tumorectomy and negative sentinel limph node, assessing the feasibility and technical reproducibility of a per-concentrated irradiationThe first treatment was a surgical operation focused on the initial tumor area as the only treatment
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Procedure: axillary lymph node dissection, Procedure: conventional surgery, Procedure: sentinel lymph node biopsy, Radiation: intraoperative radiation therapybreast conserving surgery with lymph node dissection + Intraoperative radiotherapy |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed stage I breast cancer
- Hormone receptor status not specified
Key exclusion criteria (19 listed)
- Distant metastases
- Inflammatory breast cancer
- Lobular in situ disease
- Invasive cancer or ductal carcinoma in situ
- Nonepithelial disease or sarcoma
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 |
|---|---|---|
| axillary lymph node dissection | Procedure or surgery | treatment arm |
| conventional surgery | Procedure or surgery | treatment arm |
| sentinel lymph node biopsy | Procedure or surgery | treatment arm |
| intraoperative radiation therapy | Radiation | treatment arm |
Primary outcome
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
Time frame: During the treatment of irradiation (4 weeks)
feasibility based on dosimetric criteria based on the Quality Index of the application.
Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
Time frame: During the treatment of irradiation (4 weeks)
reproducibility based on dosimetric criteria based on the Quality Index of the application.
5 secondary outcomes
impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
Time frame: from the baseline to 12 months after the treatment
impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
Time frame: from the baseline to 12 months after the treatment
Tolerability of partial irradiation of the breast by per-operative electron therapy
Time frame: from the baseline to 12 months after the treatment
Relapse-free survival
Time frame: from the baseline to 12 months after the treatment
Disease-specific survival
Time frame: from the baseline to 12 months after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 1515238Aaronson NK. Assessing the quality of life of patients in cancer clinical trials: Common problems and common sense solutions. Eur J Cancer. 1992;28A(8-9):1304-7. doi: 10.1016/0959-8049(92)90504-u. No abstract available.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 11535710Nattinger AB, Kneusel RT, Hoffmann RG, Gilligan MA. Relationship of distance from a radiotherapy facility and initial breast cancer treatment. J Natl Cancer Inst. 2001 Sep 5;93(17):1344-6. doi: 10.1093/jnci/93.17.1344. No abstract available.
- Background: PubMed 4691036Arnulf G. Lymphoedema of the upper limb after Halsted's operation of radical mastectomy.. Lymphography and phlebography. Therapeutic consequences. Vasc Surg. 1973 Jan-Feb;7(1):36-44. doi: 10.1177/153857447300700105. No abstract available.
- Background: PubMed 8622072Arriagada R, Le MG, Rochard F, Contesso G. Conservative treatment versus mastectomy in early breast cancer: patterns of failure with 15 years of follow-up data. Institut Gustave-Roussy Breast Cancer Group. J Clin Oncol. 1996 May;14(5):1558-64. doi: 10.1200/JCO.1996.14.5.1558.
- Background: PubMed 11579340Balducci L, Extermann M, Carreca I. Management of breast cancer in the older woman. Cancer Control. 2001 Sep-Oct;8(5):431-41. doi: 10.1177/107327480100800507.
- Background: PubMed 8995097Balducci L, Lyman GH. Cancer in the elderly. Epidemiologic and clinical implications. Clin Geriatr Med. 1997 Feb;13(1):1-14.
- Background: PubMed 8637025Ballard-Barbash R, Potosky AL, Harlan LC, Nayfield SG, Kessler LG. Factors associated with surgical and radiation therapy for early stage breast cancer in older women. J Natl Cancer Inst. 1996 Jun 5;88(11):716-26. doi: 10.1093/jnci/88.11.716.
- Background: PubMed 11794170Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
- Background: PubMed 2059815Bates T, Riley DL, Houghton J, Fallowfield L, Baum M. Breast cancer in elderly women: a Cancer Research Campaign trial comparing treatment with tamoxifen and optimal surgery with tamoxifen alone. The Elderly Breast Cancer Working Party. Br J Surg. 1991 May;78(5):591-4. doi: 10.1002/bjs.1800780523.
- Background: PubMed 4962239Brenier JL. The role of the Halsted operation in treatment of breast cancer. Int Surg. 1967 Mar;47(3):288-90. No abstract available.
- Background: PubMed 8482628Buchholz TA, Austin-Seymour MM, Moe RE, Ellis GK, Livingston RB, Pelton JG, Griffin TW. Effect of delay in radiation in the combined modality treatment of breast cancer. Int J Radiat Oncol Biol Phys. 1993 Apr 30;26(1):23-35. doi: 10.1016/0360-3016(93)90169-v.
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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. This study is not recruiting at the moment.
Jean-Bernard Dubois, MD study chair
Institut du Cancer de Montpellier - Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axillary lymph node dissection, conventional surgery and sentinel lymph node biopsy in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 3 inclusion and 19 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 6 Mar 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy (time frame: During the treatment of irradiation (4 weeks)). 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?
On the ClinicalTrials.gov record for NCT00556777, which also lists 67 linked publications.
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 6 Mar 2025.