3D conformal EBRTContact X-ray brachytherapy 50 kVCapecitabine →
3D conformal EBRT: External Beam Radiation Therapy
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), \< 5 cm largest diameter, \< half rectal circumference (by MRI staging), N0-N1 (any node \< 8 mm diameter on MRI), M0
2. Operable patient
3. Tumour accessible to endocavitary contact X-Ray Brachytherapy with a distance from the lower tumour border to the anal verge ≤ 10cm
4. 18 years or above
5. No comorbidity preventing treatment
6. Adequate birth control
7. Patient having read the information note and having signed the informed consent
8. Health care insurance available
9. Follow-up possible
Exclusion Criteria:
1. Inoperable patient
2. T1, T3cd, T4, T≥ 5cm, T≥ ½ circumference
3. Patient N2 at diagnosis or N1 with any node \> 8 mm diameter
4. Patient presenting metastasis at diagnosis
5. Previous pelvic irradiation
6. Tumour with extramural vascular invasion
7. Simultaneous progressive cancer
8. Tumour invading external anal sphincter and within 1 mm, and the levator muscle
9. Patient unable to receive CXB or CRT
10. Tumour with poor differentiation (G3)
11. People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside state to express their consent, pregnant or breastfeeding women
12. Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
13. Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol
14. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
Primary outcome measure(s)
Rate of rectum preservation either with local excision or watch and wait strategy after neoadjuvant treatment without non salvageable locally progressive disease at 3 years post treatment, or permanent stoma. — 3 years post treatment The primary analysis will take place when approximately 138 events have occurred.
The evaluation of the rate of rectum preservation without progressive local disease at 3 years will be performed using a Log rank test stratified by center.
Trial sites (18)
Facility
City
Region
Status
Clinique de la Sauvegarde
Lyon
Auvergne-Rhône-Alpes
CHRU Besançon
Besançon
Bourgogne-Franche-Comté
Centre Jean Godinot
Reims
Champagne-Ardenne
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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