Status:
RECRUITING
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Jules Bordet Institute
Conditions:
Locally Advanced Rectal Cancer
Older People
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age ≥ 70 years old
- ECOG performance status (PS):
- ≤1 if age \> 75 years old
- ≤2 if age ≤ 75 years old
- Histologically or cytologically confirmed adenocarcinoma of the rectum
- Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge
- Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement/threatening \[i.e.,tumour within 1 mm of the MRF\], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible.
- Adequate bone marrow function as defined below:
- Absolute neutrophil count ≥1,500/µL
- Haemoglobin ≥9 g/dL
- Platelets ≥100,000/µL
- Adequate liver function as defined below:
- Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome \<3xUNL is allowed
- AST (SGOT) and ALT (SGPT) ≤2.5 x ULN
- Alkaline phosphatase ≤2.5 x ULN
- Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² (according to the CKD-EPI 2021 equation).
- Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs.
Exclusion
- Extensive growth into cranial part of the sacrum (above S2/3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved.
- Presence of metastatic disease or recurrent rectal tumour.
- Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0.
- Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Any contraindication to pelvic irradiation as evaluated by the investigator.
- Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications.
- Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication within the past 6 months.
- Complete dihydropyrimidine dehydrogenase (DPD) deficiency.
- Any previous treatment for rectal cancer.
- Use of brivudine, sorivudine or their chemically related analogues.
Key Trial Info
Start Date :
February 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06052332
Start Date
February 7 2024
End Date
December 1 2033
Last Update
December 5 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
ZAS Antwerpen
Antwerp, Antwerpen, Belgium, 2610
2
UZA Antwerpen
Edegem, Antwerpen, Belgium, 2650
3
AZ Turnhout
Turnhout, Antwerpen, Belgium, 2300
4
Institut Jules Bordet
Anderlecht, Brussels Capital, Belgium, 1070