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ACTIVE NOT RECRUITING
NCT02505750
PHASE3

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

Sponsor: Centre Antoine Lacassagne

View on ClinicalTrials.gov

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

Interventions

RADIATION

3D conformal EBRT

External Beam Radiation Therapy

DEVICE

Contact X-ray brachytherapy 50 kV

DRUG

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