Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

Invasive Breast Cancer Clinical Trial

— INTRA-OBS  

Official title:

Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04414202
• Other study ID #: 2009/OBS-01
• Status: Active, not recruiting
• Start date: December 15, 2009
• Est. completion date: December 2030

Study information

• Verified date: June 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 519
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Women 60 years of age or older,

• Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid),

-. Unifocal tumor,

• T1 (diameter = 20 mm),

• N0 (pN0 or pNi+),

• M0,

• Gland exeresis margins = 2 mm,

• Estrogen receptor positive,

• Information and non-opposition of the patient.

Exclusion Criteria:

-. Inflammatory breast cancer,

• Associated peri-tumoral lymphatic emboli

• Associated extensive intra-ductal component

• Invasive lobular carcinoma

• Pure ductal carcinoma in situ,

• Sarcoma or lymphoma-type non-epithelial tumor

• Synchronous bilateral breast cancer,

• Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast-conserving Surgery
• Carcinoma, Ductal, Breast
• Invasive Breast Cancer

Intervention

Procedure:
• tumorectomy with axillary dissection (sentinel lymph node)
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.

Radiation:
• per-operative partial irradiation
20 Gy of per-operative partial irradiation at the tumor site during the surgery

Locations

Country	Name	City	State
France	Icm Val D'Aurelle	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local intra-mammary relapse rate	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	post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
Primary	Local intra-mammary relapse rate	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	post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
Secondary	Cosmetic results	Evaluation of the cosmetic result of questionnaire (0 from 10)	post surgery : 3 weeks, 6 months and 12 months
Secondary	Survival without metastatic relapse	Study of survival without metastatic relapse, of overall survival, of specific survival	post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
Secondary	patients' satisfaction towards the treatment	Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)	post surgery : 3 weeks, 6 months and 12 months
Secondary	Impact of the accelerated treatment on the maintenance of autonomy in elderly patients	Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL, IADL).	post surgery : 3 weeks, 6 months and 12 months

External Links

•   Institut de Veille Sanitaire- Institut National du Cancer