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Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma
Sponsor: Centre Antoine Lacassagne
Summary
The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery. The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%). Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma. Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.
Official title: European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2015-06-24
Completion Date
2030-06
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
3D conformal EBRT
External Beam Radiation Therapy
Contact X-ray brachytherapy 50 kV
Capecitabine
Locations (18)
Clinique de la Sauvegarde
Lyon, Auvergne-Rhône-Alpes, France
CHRU Besançon
Besançon, Bourgogne-Franche-Comté, France
Centre Jean Godinot
Reims, Champagne-Ardenne, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre d'oncologie et de radiothérapie Mâcon
Mâcon, France
Centre Antoine Lacassagne
Nice, France
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Clinique Charcot
Sainte-Foy-lès-Lyon, France
Hôpital de la Croix Rouge Française - Centre de Radiothérapie St Louis
Toulon, France
Centre de radiothérapie Bayard
Villeurbanne, France
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Royal Surrey County Hospital
Guildford, United Kingdom
Spire Hull and East Riding Hospital
Hull, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Christie Hospital
Manchester, United Kingdom
University Hospital
Nottingham, United Kingdom