Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Cyberknife

Philippe Nickers, MD, PhD

Michel Untereiner, MD

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).

Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.

Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.

Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35\<2cc. Bladder neck and urethra: V35\<1cc.

Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.

Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma

Delay between the initial diagnosis and date of salvage treatment

Acute and late toxicity using the CTCAEv4

Centre Francois Baclesse, Luxembourg

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma, Ductal, Breast

Carcinoma, Ductal

Breast Diseases

Skin Diseases

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

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.

tumorectomy with axillary dissection (sentinel lymph node)

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

per-operative partial irradiation

LEMANSKI Claire, DR

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

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

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

Evaluation of the cosmetic result of questionnaire (0 from 10)

Study of survival without metastatic relapse, of overall survival, of specific survival

Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)

Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL, IADL).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma	NCT03284151	Prostate Cancer	Cyberknife	-	Centre Francois Baclesse, Luxembourg
Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis	NCT04414202	Invasive Breast... Breast-conservi...	tumorectomy wit... per-operative p...	60 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

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