Pr. Nicolas Magné, MD, PhD nicolas.magne@icloire.fr

SAHGEED  

Cancer du rectum : Indications et modalités des traitements adjuvants

Cours Intensif de Cancérologie Digestive FFCD - SAHGEED 16 &17 Septembre 2016

Palais de la Culture MOUFDI Zakaria

Thésaurus SNFGE www tncd.org

3

Thésaurus Rectum 2013 www tncd. org

JP Gérard Crit Rev Oncol Hematol 2012

Sph Sphincter Saving

CXB unique RT = high precision - eye guided

Small Volume (5cm3) : SAFE HIGH DOSE

30  Gy 2 min

Transanal Endoscopic Brachytherapy

X    50  Kv  

 Contact  XB    

HIGH DOSE RATE

Day 1

uT2N0

Day 70

pT0N0 14 years

1999

cCR  

Neoadjuvant Treatment and cCR

cCR : 30-50% cCR : 60-85%

EBRT EBRT + boost endocavitary

             

•  Une escalade de dose sans toxicité grâce à la RT Contact

90 Gy / 3 séancee •  Double les chances d’une Réponse clinique

complète qui permet une exérèse locale

RT de CONTACT Papillon

Philips CXB 50 Kv

1968

1971

cCR

30 Gy 2mn

30 Gy

Papillon + 2015

11

Organ Preservation in Early Rectal

Adenocarcinoma

OPERA

Sponsor : Centre Antoine Lacassagne, Nice France

Investigator coordinator : J.P. Gérard - Nice

Rationale OPERA

Ø  Standard treatment T2-3 : TME

Even with ant-Resect. : bowel function

Ø  Habr Gama : CRT – CCR – W.W. (surveillance)

Ø  Contact x ray brachytherapy : 50 kv

Papillon 50TM : renaissance CXB

Liverpool – Clatterbridge – France – DK –

Sweeden

CXB boost vs CRT-EBRT (Habr G) : 30%

Primary objective

To demonstrate that neoadjuvant CRT with a

CXB boost (arm B) is superior to same CRT

with EBRT boost (arm A) :

Rectum (organ) preservation at 3 years without

non salvageable local disease and permanent

derivative stoma

Secondary objectives

Efficacy :

Ø  cCR – Tumour regression clinical – pathological

Ø  Rate of sphincter preservation

Ø  Survival – OS – DFS – SS

Safety :

Ø  Early – late toxicity (NCI – CTCAEV 4.0)

Ø  Bowel function (modified LARS score)

Ø  QOL (QLQ – C30, QLQ – CR29)

Inclusion criteria

Ø  Operable patient ≥ 18 years Ø  Adenocarcinoma ≤ 10 cm anal Verge (lower, …) Ø  cT2 cT3a cT3b (fat 1 to 5 mm) Ø  < 5 cm diameter < ½ circumference (MRI) Ø  N0 – N1 (L.N. < 8 mm) – M0 Ø  No comorbidity preventing to perform treatment Ø  Adequate birth control Ø  Signed informed consent – health care insurance -

Fup

M 69 y , T 3a N 0 (MRI)

April 2014

4- 2014 M 69y MRI :T3a N0 CXB 90 Gy/3f + CAP 50

cCR 8-2014 - Loc Exc:ypT0 03-2015 NED

D1

D28

Middle rectum Anal canal : 3 cm Lower Border T : 5+3 cm = 8cm Accessible to DRE

T classification Nougaret et al. Radiology 2013

T3 a < 1 mm beyond Mus.Prop. T3b ≥ 1-5 mm T3c > 5-15 mm T3 d > 15 mm