<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04414202</url>
  </required_header>
  <id_info>
    <org_study_id>2009/OBS-01</org_study_id>
    <nct_id>NCT04414202</nct_id>
  </id_info>
  <brief_title>Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis</brief_title>
  <acronym>INTRA-OBS</acronym>
  <official_title>Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors&#xD;
      diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65&#xD;
      years of age, with specific survival of 98% at 5 years.&#xD;
&#xD;
      The treatment of these tumors combines breast-conserving surgery and external whole breast&#xD;
      irradiation for 6.5 weeks.&#xD;
&#xD;
      A true de-escalation of treatment is taking place with these tumors, both surgically and&#xD;
      medically. Surgery therefore now prefers breast-conserving methods in combination with&#xD;
      exeresis of the sentinel lymph node only. In the same way, in many international studies,&#xD;
      radiotherapy has been evaluating the possibility of reducing both:&#xD;
&#xD;
        -  the irradiation volume at the excision site (partial irradiation)&#xD;
&#xD;
        -  the duration of this irradiation (accelerated radiotherapy)&#xD;
&#xD;
      Between 2004 and 2007, the CRLC [Regional Anti-Cancer Center] evaluated the feasibility and&#xD;
      the oncological results of intra-operative partial irradiation via a phase II study in women&#xD;
      65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis.&#xD;
&#xD;
      From 2010 to 2013, the ICM carried out an observational study of these tumors with an&#xD;
      excellent prognosis.&#xD;
&#xD;
      In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus&#xD;
      statement with specific recommendations and indications for accelerated partial breast&#xD;
      irradiation (APBI).&#xD;
&#xD;
      This APBI technique has been developing in France over the past 5 years within the framework&#xD;
      of clinical studies and in compliance with the 2012 recommendations of the French National&#xD;
      Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by&#xD;
      intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of&#xD;
      the surrounding healthy tissue as possible.&#xD;
&#xD;
      The Investigator therefore propose a cohort study to prospectively analyze the results of&#xD;
      this technique applied to the indications strictly defined by the ASTRO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      after registration, particpants have as treatment &quot;combination extended tumorectomy with&#xD;
      axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial&#xD;
      irradiation at the tumor site.&#xD;
&#xD;
      follow up after this treatment during 5 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 15, 2009</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Local intra-mammary relapse rate</measure>
    <time_frame>post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)</time_frame>
    <description>The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local intra-mammary relapse rate</measure>
    <time_frame>post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)</time_frame>
    <description>The local relapse rate, defined as the number of intramammary relapses in the homolateral lymph node, appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cosmetic results</measure>
    <time_frame>post surgery : 3 weeks, 6 months and 12 months</time_frame>
    <description>Evaluation of the cosmetic result of questionnaire (0 from 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival without metastatic relapse</measure>
    <time_frame>post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)</time_frame>
    <description>Study of survival without metastatic relapse, of overall survival, of specific survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients' satisfaction towards the treatment</measure>
    <time_frame>post surgery : 3 weeks, 6 months and 12 months</time_frame>
    <description>Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the accelerated treatment on the maintenance of autonomy in elderly patients</measure>
    <time_frame>post surgery : 3 weeks, 6 months and 12 months</time_frame>
    <description>Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL, IADL).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">519</enrollment>
  <condition>Invasive Breast Cancer</condition>
  <condition>Breast-conserving Surgery</condition>
  <arm_group>
    <arm_group_label>1 GROUP</arm_group_label>
    <description>Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.&#xD;
The treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tumorectomy with axillary dissection (sentinel lymph node)</intervention_name>
    <description>All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.</description>
    <arm_group_label>1 GROUP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>per-operative partial irradiation</intervention_name>
    <description>20 Gy of per-operative partial irradiation at the tumor site during the surgery</description>
    <arm_group_label>1 GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Invasive breast cancer with a good prognosis that is accessible to breast-conserving&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women 60 years of age or older,&#xD;
&#xD;
          -  Histologically proven invasive ductal breast cancer or of a histologically favorable&#xD;
             sub-type (mucinous, tubular or colloid),&#xD;
&#xD;
             -. Unifocal tumor,&#xD;
&#xD;
          -  T1 (diameter ≤ 20 mm),&#xD;
&#xD;
          -  N0 (pN0 or pNi+),&#xD;
&#xD;
          -  M0,&#xD;
&#xD;
          -  Gland exeresis margins ≥ 2 mm,&#xD;
&#xD;
          -  Estrogen receptor positive,&#xD;
&#xD;
          -  Information and non-opposition of the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -. Inflammatory breast cancer,&#xD;
&#xD;
          -  Associated peri-tumoral lymphatic emboli&#xD;
&#xD;
          -  Associated extensive intra-ductal component&#xD;
&#xD;
          -  Invasive lobular carcinoma&#xD;
&#xD;
          -  Pure ductal carcinoma in situ,&#xD;
&#xD;
          -  Sarcoma or lymphoma-type non-epithelial tumor&#xD;
&#xD;
          -  Synchronous bilateral breast cancer,&#xD;
&#xD;
          -  Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LEMANSKI Claire, DR</last_name>
    <role>Study Chair</role>
    <affiliation>ICM Val d'Aurelle DRCI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icm Val D'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34398</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.e-cancer.fr/</url>
    <description>Institut de Veille Sanitaire- Institut National du Cancer</description>
  </link>
  <reference>
    <citation>Grosclaude P, Colonna M, Hedelin G, Tretarre B, Arveux P, Lesec'h JM, Raverdy N, Sauvage-Machelard M. Survival of women with breast cancer in france: variation with age, stage and treatment. Breast Cancer Res Treat. 2001 Nov;70(2):137-43. doi: 10.1023/a:1012974728007.</citation>
    <PMID>11768604</PMID>
  </reference>
  <reference>
    <citation>van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.</citation>
    <PMID>10904087</PMID>
  </reference>
  <reference>
    <citation>Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.</citation>
    <PMID>12393819</PMID>
  </reference>
  <reference>
    <citation>Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.</citation>
    <PMID>16360786</PMID>
  </reference>
  <reference>
    <citation>Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.</citation>
    <PMID>17577015</PMID>
  </reference>
  <reference>
    <citation>Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7. doi: 10.1159/000061160. No abstract available.</citation>
    <PMID>9263806</PMID>
  </reference>
  <reference>
    <citation>Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. doi: 10.1016/j.ijrobp.2005.10.025. Epub 2006 Jan 25.</citation>
    <PMID>16442241</PMID>
  </reference>
  <reference>
    <citation>Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.</citation>
    <PMID>19467579</PMID>
  </reference>
  <reference>
    <citation>Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009 Aug;209(2):269-77. doi: 10.1016/j.jamcollsurg.2009.02.066. Epub 2009 Apr 24. No abstract available.</citation>
    <PMID>19632605</PMID>
  </reference>
  <reference>
    <citation>Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.</citation>
    <PMID>12393820</PMID>
  </reference>
  <reference>
    <citation>Vlastos G, Mirza NQ, Meric F, Hunt KK, Kuerer HM, Ames FC, Ross MI, Buchholz TA, Hortobagyi GN, Singletary SE. Breast conservation therapy as a treatment option for the elderly. The M. D. Anderson experience. Cancer. 2001 Sep 1;92(5):1092-100. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-p.</citation>
    <PMID>11571720</PMID>
  </reference>
  <reference>
    <citation>Vinh-Hung V, Verschraegen C. Breast-conserving surgery with or without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst. 2004 Jan 21;96(2):115-21. doi: 10.1093/jnci/djh013.</citation>
    <PMID>14734701</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>good prognosis</keyword>
  <keyword>surgery</keyword>
  <keyword>intra-operative partial irradiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04414202
org study id: 2009/OBS-01
nct id: NCT04414202
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors
      diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65
      years of age, with specific survival of 98% at 5 years.

      The treatment of these tumors combines breast-conserving surgery and external whole breast
      irradiation for 6.5 weeks.

      A true de-escalation of treatment is taking place with these tumors, both surgically and
      medically. Surgery therefore now prefers breast-conserving methods in combination with
      exeresis of the sentinel lymph node only. In the same way, in many international studies,
      radiotherapy has been evaluating the possibility of reducing both:

        -  the irradiation volume at the excision site (partial irradiation)

        -  the duration of this irradiation (accelerated radiotherapy)

      Between 2004 and 2007, the CRLC [Regional Anti-Cancer Center] evaluated the feasibility and
      the oncological results of intra-operative partial irradiation via a phase II study in women
      65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis.

      From 2010 to 2013, the ICM carried out an observational study of these tumors with an
      excellent prognosis.

      In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus
      statement with specific recommendations and indications for accelerated partial breast
      irradiation (APBI).

      This APBI technique has been developing in France over the past 5 years within the framework
      of clinical studies and in compliance with the 2012 recommendations of the French National
      Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by
      intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of
      the surrounding healthy tissue as possible.

      The Investigator therefore propose a cohort study to prospectively analyze the results of
      this technique applied to the indications strictly defined by the ASTRO.
after registration, particpants have as treatment "combination extended tumorectomy with
      axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial
      irradiation at the tumor site.

      follow up after this treatment during 5 years
observational model: Cohort
time perspective: Prospective
measure: Local intra-mammary relapse rate
time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
description: The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre
measure: Local intra-mammary relapse rate
time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
description: The local relapse rate, defined as the number of intramammary relapses in the homolateral lymph node, appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre
measure: Cosmetic results
time frame: post surgery : 3 weeks, 6 months and 12 months
description: Evaluation of the cosmetic result of questionnaire (0 from 10)
measure: Survival without metastatic relapse
time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
description: Study of survival without metastatic relapse, of overall survival, of specific survival
measure: patients' satisfaction towards the treatment
time frame: post surgery : 3 weeks, 6 months and 12 months
description: Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
measure: Impact of the accelerated treatment on the maintenance of autonomy in elderly patients
time frame: post surgery : 3 weeks, 6 months and 12 months
description: Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL, IADL).
arm group label: 1 GROUP
description: Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.
The treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years
intervention type: Procedure
intervention name: tumorectomy with axillary dissection (sentinel lymph node)
description: All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.
arm group label: 1 GROUP
intervention type: Radiation
intervention name: per-operative partial irradiation
description: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
arm group label: 1 GROUP
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: LEMANSKI Claire, DR
role: Study Chair
affiliation: ICM Val d'Aurelle DRCI
facility: 
country: France
url: https://www.e-cancer.fr/
description: Institut de Veille Sanitaire- Institut National du Cancer
citation: Grosclaude P, Colonna M, Hedelin G, Tretarre B, Arveux P, Lesec'h JM, Raverdy N, Sauvage-Machelard M. Survival of women with breast cancer in france: variation with age, stage and treatment. Breast Cancer Res Treat. 2001 Nov;70(2):137-43. doi: 10.1023/a:1012974728007.
PMID: 11768604
citation: van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.
PMID: 10904087
citation: Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.
PMID: 12393819
citation: Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
PMID: 16360786
citation: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.
PMID: 17577015
citation: Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7. doi: 10.1159/000061160. No abstract available.
PMID: 9263806
citation: Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. doi: 10.1016/j.ijrobp.2005.10.025. Epub 2006 Jan 25.
PMID: 16442241
citation: Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.
PMID: 19467579
citation: Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009 Aug;209(2):269-77. doi: 10.1016/j.jamcollsurg.2009.02.066. Epub 2009 Apr 24. No abstract available.
PMID: 19632605
citation: Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PMID: 12393820
citation: Vlastos G, Mirza NQ, Meric F, Hunt KK, Kuerer HM, Ames FC, Ross MI, Buchholz TA, Hortobagyi GN, Singletary SE. Breast conservation therapy as a treatment option for the elderly. The M. D. Anderson experience. Cancer. 2001 Sep 1;92(5):1092-100. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-p.
PMID: 11571720
citation: Vinh-Hung V, Verschraegen C. Breast-conserving surgery with or without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst. 2004 Jan 21;96(2):115-21. doi: 10.1093/jnci/djh013.
PMID: 14734701
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Carcinoma, Ductal, Breast
sharing ipd: No