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

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.

Conditions

• Rectal Neoplasms

Interventions

RADIATION

3D conformal EBRT

External Beam Radiation Therapy

DEVICE

Contact X-ray brachytherapy 50 kV

DRUG

Capecitabine

Sponsors & Collaborators

• Centre de Haute Energie

  collaborator UNKNOWN

• Centre Azuréen de Cancérologie

  collaborator UNKNOWN

• Hôpital de la Croix-Rousse

  collaborator OTHER

• Institut Paoli-Calmettes

  collaborator OTHER

• Hôpital de la Timone

  collaborator OTHER

• Centre de radiothérapie Bayard

  collaborator UNKNOWN

• Centre Oncologie Radiothérapie de Mâcon

  collaborator UNKNOWN

• Centre Leon Berard

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• Clinique Charcot

  collaborator UNKNOWN

• Institut de Cancérologie Lucien Neuwirth

  collaborator UNKNOWN

• The Clatterbridge Cancer Centre NHS Foundation Trust

  collaborator OTHER

• Spire Hull and East Riding Hospital

  collaborator UNKNOWN

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Royal Surrey County Hospital NHS Foundation Trust

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Centre Antoine Lacassagne

  lead OTHER

Principal Investigators

• Jérôme DOYEN, M.D, PhD · Centre Antoine Lacassagne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-24

Primary Completion

2023-06-07

Completion

2030-06-30

Countries

• France
• Switzerland
• United Kingdom

Study Locations