Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS).
R Saúde-Conde, T Vandamme, M De Backer...
https://pubmed.ncbi.nlm.nih.gov/41648032Actively Recruiting
Phase Not Applicable
Age: 70Years +
All Genders
ID06052332
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial
Led by Jules Bordet Institute · Updated on 2025-12-05
230
Participants Needed
19
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for older adults aged 70 years and above who have high-risk stage II or stage III locally advanced rectal cancer. This multicenter, open-label, randomized clinical trial compares two standard neoadjuvant therapy approaches to see how they work in this population. The study focuses on assessing overall survival, progression-free survival, nerve-related side effects, and serious toxicities at 3 years after treatment begins. Participants will be randomly assigned to one of two treatment groups. The conventional group receives either short-course radiotherapy (five doses of 5 Gy) followed by surgery or a watchful waiting approach, with optional chemotherapy after surgery; or long-course chemoradiotherapy (25-28 doses totaling 50-56 Gy combined with chemotherapy) followed by surgery or watchful waiting, and optional chemotherapy. The total neoadjuvant therapy (TNT) group may receive one of several regimens involving combinations of short-course radiotherapy, long-course chemoradiotherapy, and oxaliplatin-based chemotherapy for up to 18 weeks, followed by surgery or watchful waiting. Throughout the study, participants will undergo medical assessments, including monitoring for survival and disease progression over 3 years. Researchers will also evaluate peripheral sensory neuropathy and other treatment-related toxicities during this period. The choice of specific chemotherapy regimens in the TNT group is decided before randomization and remains fixed. Participants will be closely monitored to track treatment effects and side effects until the study ends in December 2033.
CONDITIONS
Brief Title
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Who Can Participate
Age: 70Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- ECOG performance status of 1 or less if older than 75 years
- ECOG performance status of 2 or less if 75 years or younger
- Histologically or cytologically confirmed adenocarcinoma of the rectum
- Tumour distal border below the peritoneal reflection and within 15 cm of the anal verge
- Operable stage III or high-risk stage II rectal cancer with specific high-risk features
- Adequate bone marrow function with neutrophils ≥1500/µL, hemoglobin ≥9 g/dL, and platelets ≥100,000/µL
- Adequate liver function with bilirubin ≤1.5 times upper limit normal (ULN), AST and ALT ≤2.5 times ULN, alkaline phosphatase ≤2.5 times ULN
- Adequate kidney function with estimated GFR ≥30 mL/min/1.73m²
- No clinical conditions contraindicating neoadjuvant therapy or surgery
- Signed informed consent form
- Male participants with partners of childbearing potential must agree to use condoms during and for 6 months after treatment
You will not qualify if you...
- Extensive tumour growth into upper sacrum or lumbosacral nerve roots making surgery impossible
- Presence of metastatic disease or recurrent rectal tumour
- Grade 2 or higher peripheral neuropathy
- Significant uncontrolled medical, neuro-psychiatric, or surgical conditions
- Contraindications to pelvic irradiation
- Known hypersensitivity to study drugs or related medications
- Previous investigational anti-cancer therapy other than protocol treatments
- Prior or concurrent malignancies interfering with safety or efficacy assessment
- Active serious cardiovascular disease within past 6 months
- Complete dihydropyrimidine dehydrogenase (DPD) deficiency
- Any previous treatment for rectal cancer
- Use of brivudine, sorivudine, or related drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Several weeks to up to approximately 18 weeks depending on the assigned regimen
Participants receive either conventional neoadjuvant therapy or total neoadjuvant therapy as assigned. Conventional therapy includes short course radiotherapy or long course chemoradiotherapy, followed by surgery or a watch & wait approach, with optional adjuvant chemotherapy. Total neoadjuvant therapy involves various regimens combining radiotherapy and chemotherapy before surgery or watch & wait, depending on the assigned regimen.
Multiple visits for radiotherapy and chemotherapy as per treatment schedule, including surgery or watch & wait assessment
Follow-up
Duration - Up to 3 years after randomisation
Participants are monitored for overall survival, progression-free survival, peripheral neuropathy, and treatment-related toxicities up to 3 years after randomisation.
Regular follow-up visits over 3 years
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
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Research Team
S
Sophie Lepannetier, phD
I
Ikram El Idrissi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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