Comparing two treatment options for older patients with advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SHAPERS study is a multicentre, open-label, randomised clinical trial designed to compare the efficacy and safety of short course radiotherapy (SCRT) versus total neoadjuvant therapy (TNT) in older patients aged 70 and above with high-risk stage II and stage III rectal cancer. Participants will be randomly assigned to one of the two treatment arms, with SCRT followed by surgery or watch & wait, or various regimens of TNT followed by surgery or watch & wait. The study aims to determine which treatment approach provides better outcomes for this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• ZAS Antwerpen
  Antwerp, Antwerpen, Belgium Recruiting
• UZA Antwerpen
  Edegem, Antwerpen, Belgium Recruiting
• AZ Turnhout
  Turnhout, Antwerpen, Belgium Recruiting
• Institut Jules Bordet
  Anderlecht, Brussels Capital, Belgium Recruiting
• Chirec Delta
  Auderghem, Brussels Capital, Belgium Recruiting
• CHU Saint-Pierre
  Brussels, Brussels Capital, Belgium Recruiting

Study contacts

• Study coordinator: Sophie Lepannetier, phD
• Email: ctsu.shapers@hubruxelles.be
• Phone: +32 (0)2 541 34 56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.