Overview

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

Status:
Active, not recruiting

Trial end date:
2022-09-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Centre Antoine Lacassagne

Collaborators:

Aarhus University Hospital
Centre Azuréen de Cancérologie
Centre de Haute Energie
Centre de radiothérapie Bayard
Centre Leon Berard
Centre Oncologie Radiothérapie de Mâcon
Clinique Charcot
Hôpital de la Croix-Rousse
Hôpital de la Timone
Hospices Civils de Lyon
Institut de Cancérologie Lucien Neuwirth
Institut Paoli-Calmettes
Karolinska Institutet
Nottingham University Hospitals NHS Trust
Royal Surrey County Hospital
Royal Surrey County Hospital NHS Foundation Trust
Spire Hull and East Riding Hospital
The Clatterbridge Cancer Centre NHS Foundation Trust
Uppsala University Hospital

Treatments:

Capecitabine