NCT06052332 Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
| NCT ID | NCT06052332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jules Bordet Institute |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2024-02-07 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 II and stage III rectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 70 years old 2. ECOG performance status (PS): * ≤1 if age \> 75 years old * ≤2 if age ≤ 75 years old 3. Histologically or cytologically confirmed adenocarcinoma of the rectum 4. Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge 5. 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. 6. Adequate bone marrow function as defined below: * Absolute neutrophil count ≥1,500/µL * Haemoglobin ≥9 g/dL * Platelets ≥100,000/µL 7. 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 8. Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² (according to the CKD-EPI 2021 equation). 9. Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery. 10. Signed Informed Consent form (ICF) obtained prior to any study related procedure. 11. 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 Criteria: 1. 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. 2. Presence of metastatic disease or recurrent rectal tumour. 3. Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0. 4. 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. 5. Any contraindication to pelvic irradiation as evaluated by the investigator. 6. Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications. 7. 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). 8. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment. 9. 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. 10. Complete dihydropyrimidine dehydrogenase (DPD) deficiency. 11. Any previous treatment for rectal cancer. 12. Use of brivudine, sorivudine or their chemically related analogues.
Contact & Investigator
Francesco Sclafani
STUDY CHAIR
Jules Bordet Institute
Frequently Asked Questions
Who can join the NCT06052332 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Locally Advanced Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06052332 currently recruiting?
Yes, NCT06052332 is actively recruiting participants. Contact the research team at ctsu.shapers@hubruxelles.be for enrollment information.
Where is the NCT06052332 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Edegem, Belgium, Turnhout, Belgium, Anderlecht, Belgium and 11 additional locations.
Who is sponsoring the NCT06052332 clinical trial?
NCT06052332 is sponsored by Jules Bordet Institute. The principal investigator is Francesco Sclafani at Jules Bordet Institute. The trial plans to enroll 230 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.