Actively Recruiting
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Led by Jules Bordet Institute · Updated on 2025-12-05
230
Participants Needed
19
Research Sites
512 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.
CONDITIONS
Official Title
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- ECOG performance status of 1 if older than 75 years, or 2 if 75 years or younger
- Histologically or cytologically confirmed adenocarcinoma of the rectum
- Tumor located below the peritoneal reflection and within 15 cm of the anal verge
- Operable stage III or high-risk stage II rectal cancer, with high-risk defined by features such as T4 tumor, mesorectal fascia involvement within 1 mm, extramural venous invasion, or lateral pelvic lymph node involvement
- Adequate bone marrow function: absolute neutrophil count ≥ 1,500/µL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/µL
- Adequate liver function: total bilirubin ≤ 1.5 times upper normal limit (up to <3 times allowed for Gilbert's syndrome), AST and ALT ≤ 2.5 times upper normal limit, alkaline phosphatase ≤ 2.5 times upper normal limit
- Adequate renal function with estimated glomerular filtration rate ≥ 30 mL/min/1.73m²
- No clinical conditions contraindicating neoadjuvant therapy or surgery as judged by the investigator
- Signed informed consent form
- Male subjects with partners of childbearing potential must agree to use condoms during the study and for 6 months after last study drug administration
You will not qualify if you...
- Extensive tumor growth into the upper sacrum (above S2/3) or lumbosacral nerve roots making surgery impossible
- Presence of metastatic disease or recurrent rectal tumor
- Grade 2 or higher peripheral neuropathy
- Significant uncontrolled medical, neuro-psychiatric, or surgical conditions that may interfere with study completion
- Contraindication to pelvic irradiation
- Known hypersensitivity to study drugs or related products
- Participation in other investigational anti-cancer therapies not specified in the protocol
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Active significant cardiovascular disease within past 6 months, including stroke, myocardial infarction, unstable angina, severe heart failure, or serious arrhythmia requiring medication
- Complete dihydropyrimidine dehydrogenase deficiency
- Previous treatment for rectal cancer
- Use of brivudine, sorivudine, or related analogues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
ZAS Antwerpen
Antwerp, Antwerpen, Belgium, 2610
Actively Recruiting
2
UZA Antwerpen
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
3
AZ Turnhout
Turnhout, Antwerpen, Belgium, 2300
Actively Recruiting
4
Institut Jules Bordet
Anderlecht, Brussels Capital, Belgium, 1070
Actively Recruiting
5
Chirec Delta
Auderghem, Brussels Capital, Belgium, 1160
Actively Recruiting
6
CHU Saint-Pierre
Brussels, Brussels Capital, Belgium, 1000
Actively Recruiting
7
CHU Brugmann
Brussels, Brussels Capital, Belgium, 1020
Actively Recruiting
8
UZ Gent
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
9
AZ Nikolaas
Sint-Niklaas, East Flanders, Belgium, 9100
Actively Recruiting
10
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, Belgium, 7100
Actively Recruiting
11
Epicura
Hornu, Hainaut, Belgium, 7301
Actively Recruiting
12
CHU Ambroise Pare
Mons, Hainaut, Belgium, 7000
Not Yet Recruiting
13
CHU de Liège - Sart Tilman
Liège, Liège, Belgium, 4000
Actively Recruiting
14
CHA Libramont
Libramont, Luxemburg, Belgium, 6800
Actively Recruiting
15
Grand Hôpital De Charleroi
Charleroi, Namur, Belgium, 6000
Suspended
16
CHU Charleroi
Charleroi, Namur, Belgium, 6042
Not Yet Recruiting
17
CHU UCL Namur
Godinne, Namur, Belgium, 5530
Actively Recruiting
18
CHR Sambre et Meuse (site Meuse)
Namur, Namur, Belgium, 5000
Not Yet Recruiting
19
CHU St Elisabeth
Namur, Namur, Belgium, 5000
Actively Recruiting
Research Team
S
Sophie Lepannetier, phD
CONTACT
I
Ikram El Idrissi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here