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Locally Advanced Rectal CancerSHAPERSNCT06052332

Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer

A study testing Short course radiotherapy, Adjuvant chemotherapy (optional) and Total mesorectal excision in people with Locally Advanced Rectal Cancer and Older People, run by Jules Bordet Institute at 19 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Locally Advanced Rectal Cancer, Older People
What is being tested?
Short course radiotherapy, Adjuvant chemotherapy (optional) and Total mesorectal excision
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
19 sitesBelgium
Study dates
7 Feb 2024to Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sophie Lepannetier, phD contact

+32 (0)2 541 34 56

ctsu.shapers@hubruxelles.be

Ikram El Idrissi contact

+32 (0)2 541 30 81

ctsu.shapers@hubruxelles.be

19 sites in 1 country

Belgium19 sites, 18 recruiting

  • Institut Jules Bordet

    Anderlecht, Brussels Capital, 1070

    Rita Institut Jules Bordet, MD, rita.saudeconde@hubruxelles.be

    Rita Saude Conde, MD

    Recruiting

  • ZAS Antwerpen

    Antwerp, Antwerpen, 2610

    Ines Joye, MD, ines.joye@gza.be

    Ines Joye, MD

    Recruiting

  • Chirec Delta

    Auderghem, Brussels Capital, 1160

    Francesco Puleo, MD, francesco_puleo@hotmail.com

    Francesco Puleo, MD

    Recruiting

  • CHU Saint-Pierre

    Brussels, Brussels Capital, 1000

    Amelie Deleporte, MD, amelie.deleporte@stpierre-bru.be

    Amelie Deleporte, MD

    Recruiting

  • CHU Brugmann

    Brussels, Brussels Capital, 1020

    Sylvie Lecomte, MD, sylvie.lecomte@chu-brugmann.be

    Sylvie Lecomte, MD

    Recruiting

  • Grand Hôpital De Charleroi

    Charleroi, Namur, 6000

    Suspended

  • CHU Charleroi

    Charleroi, Namur, 6042

    Angélique Covas, MD, angelique.covas@humani.be

    Angélique Covas, MD

    Not yet recruiting

  • UZA Antwerpen

    Edegem, Antwerpen, 2650

    Timon Vandamme, MD, oncotrials@uza.be

    Timon Vandamme, MD

    Recruiting

  • UZ Gent

    Ghent, East Flanders, 9000

    Karen Geboes, MD, karen.geboes@uzgent.be

    Karen Geboes, MD

    Recruiting

  • CHU UCL Namur

    Godinne, Namur, 5530

    Lionel D'Hondt, MD, lionel.dhondt@chuuclnamur.uclouvain.be

    Lionel D'hondt, MD

    Recruiting

  • Hôpital de Jolimont

    Haine-Saint-Paul, Hainaut, 7100

    Alexandre Dermine, MD, Alexandre.DERMINE@jolimont.be

    Alexandre Dermine, MD

    Recruiting

  • Epicura

    Hornu, Hainaut, 7301

    Sandra Mupingu, MD, sandra.mupingumwanawa@epicura.be

    Sandra Mupingu, MD

    Recruiting

  • CHA Libramont

    Libramont, Luxemburg, 6800

    Frederic Forget, MD, frederic.forget@vivalia.be

    Frederic Forget, MD

    Recruiting

  • CHU de Liège - Sart Tilman

    Liège, Liège, 4000

    Elodie Gonne, MD, egonne@chuliege.be

    Elodie GONNE, MD

    Recruiting

  • CHU Ambroise Pare

    Mons, Hainaut, 7000

    Marie Diaz, MD, marie.diaz@helora.be

    Marie Diaz, MD

    Not yet recruiting

  • CHR Sambre et Meuse (site Meuse)

    Namur, Namur, 5000

    Yeter Gokburun, MD, yeter.gokburun@chrsm.be

    Yeter Gokburun, MD

    Not yet recruiting

  • CHU St Elisabeth

    Namur, Namur, 5000

    Donatienne Taylor, MD, donatienne.taylor@chuuclnamur.uclouvain.be

    Donatienne Taylor, MD

    Recruiting

  • AZ Nikolaas

    Sint-Niklaas, East Flanders, 9100

    Willem Lybaert, MD, willem.lybaert@telenet.be

    Willem Lybaert, MD

    Recruiting

  • AZ Turnhout

    Turnhout, Antwerpen, 2300

    Leen Mortier, MD, leen.mortier@azturnout.be

    Leen Mortier, MD

    Recruiting

Other trials in Belgium

About this study

Official title: 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

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.

Read the 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 II and stage III rectal cancer.

Subjects meeting all eligibility criteria will be randomised in a 1:1 ratio to either the conventional arm or the TNT arm (The study design is shown in figure 3.1 and 3.2).

Conventional arm consists of:

  • SCRT (5 fractions of 5 Gy), followed by
  • Surgery (according to the principles of TME) or watch \& wait, followed by
  • Optional adjuvant chemotherapy OR
  • LCCRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by
  • Surgery (according to the principles of TME) or watch \& wait, followed by
  • Optional adjuvant chemotherapy

TNT arm Different treatment regimens can be used in the TNT arm including Rapido, Rapido light, OPRA INCT-CRT or OPRA CRT-CNCT. The regimen to use will be decided by the investigator and will need to be declared before randomisation. No switch between regimens is allowed during the study treatment period.

The Rapido regimen consists of:

  • SCRT (5 fractions of 5 Gy), followed by
  • Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by
  • Surgery (according to the principle of TME) or "watch \& wait".

The Rapido light regimen consists of:

  • SCRT (5 fractions of 5 Gy), followed by
  • Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by
  • Surgery (according to the principle of TME) or "watch \& wait".

The OPRA with induction chemotherapy (INCT-CRT) regimen, consists of:

  • Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by
  • CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by
  • Surgery (according to the principle of TME) or "watch \& wait"

The OPRA with consolidation chemotherapy (CRT-CNCT) regimen consists of:

  • CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by
  • Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by
  • Surgery (according to the principle of TME) or "watch \& wait".
Being tested
Short course radiotherapy, Adjuvant chemotherapy (optional), Total mesorectal excision, Total neoadjuvant therapy, Long course chemoradiotherapy
Keywords
rectal cancer
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short course radiotherapyRadiation

    Patients will receive 5 daily fractions of radiotherapy. Each fraction will consist of 5 Gy for a total dose of 25 Gy.

  • Adjuvant chemotherapy (optional)Drug

    The choice of the adjuvant chemotherapy is to the investigator's discretion.

  • Total mesorectal excisionProcedure or surgery

    Surgery must be performed according to the principles of total mesorectal excision. A "watch \& wait" approach is allowed for those subjects who have clinical complete response according to the local assessment.

  • Total neoadjuvant therapyCombination product

    The choice of the TNT is left to the investigator's discretion.

    If RAPIDO:

    • SCRT (5 fractions of 5 Gy), followed by
    • Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)

    If RAPIDO light:

    • SCRT (5 fractions of 5 Gy), followed by
    • Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)

    If OPRA with induction chemotherapy:

    • Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by
    • CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine)

    If OPRA with consolidation chemotherapy:

    • CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by
    • Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX)

  • Long course chemoradiotherapyRadiation

    Patients will receive 25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine

Study groups in NCT06052332
Study groupRoleWhat they receive
Conventional armExperimental* SCRT (5 fractions of 5 Gy) * Surgery (according to the principle of TME) or watch \& wait * Optional adjuvant chemotherapy OR * LCCRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by * Surgery (according to the principles of TME) or watch \& wait, followed by * Optional adjuvant chemotherapy
Receives: Radiation: Short course radiotherapy; Drug: Adjuvant chemotherapy (optional); Procedure: Total mesorectal excision; Radiation: Long course chemoradiotherapy
TNT armActive comparatorRapido regimen: * SCRT (5 fractions of 5 Gy) * Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX) * Surgery (according to the principle of TME) or "watch \& wait" Or Rapido light regimen: * SCRT * Up to 12 weeks of oxaliplatin based chemotherapy * Surgery or "watch \& wait" Or OPRA with induction chemotherapy (INCT-CRT) regimen: * Up to 16 weeks of oxaliplatin-based chemotherapy * CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) * Surgery or "watch \& wait" Or OPRA with consolidation chemotherapy (CRT-CNCT) regimen: * CRT * Up to 16 weeks of oxaliplatin-based chemotherapy * Surgery or "watch \& wait"
Receives: Procedure: Total mesorectal excision; Combination Product: Total neoadjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival (OS) will be calculated from randomisation to death from any cause.

    Measured: At 3 years after randomisation

  2. Progression-free survival

    Progression-free survival (PFS) will be calculated from randomisation to any of the following events: unresectable tumour due to local tumour progression, R2 resection of the primary tumour, loco-regional recurrence after an R0/R1 resection, distant metastases, or death from any cause.

    Measured: At 3 years after randomisation

  3. Any grade peripheral sensory neuropathy

    Any grade peripheral sensory neuropathy as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.

    Measured: At 3 years after randomisation

  4. Grade ≥3 toxicities during treatment

    Grade ≥3 toxicities during treatment (i.e., from the 1st day of treatment until the EOT visit) as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.

    Measured: At 3 years after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start7 Feb 2024
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06052332
Sponsor's protocol ID
IJB-SHAPERS-ODN-013
Acronym
SHAPERS
Status last verified
Nov 2025
First submitted
18 Sep 2023
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Saude-Conde R, Vandamme T, De Backer M, Martinive P, Covas A, Deleporte A, Dermine A, Forget F, Geboes K, Gilliaux Q, Gokburun Y, Gonne E, Joye I, Lecomte S, Liberale G, Lybaert W, Moretti L, Mortier L, Mupingu Mwanawa S, Puleo F, Saad ED, Sinapi I, Annemans L, Buyse M, Sclafani F. Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS). ESMO Gastrointest Oncol. 2024 Jun 5;4:100067. doi: 10.1016/j.esmogo.2024.100067. eCollection 2024 Jun.

    PubMed 41648032

Questions about this trial

What is this clinical trial studying?

A study testing Short course radiotherapy, Adjuvant chemotherapy (optional) and Total mesorectal excision in people with Locally Advanced Rectal Cancer and Older People, run by Jules Bordet Institute at 19 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sophie Lepannetier, phD (+32 (0)2 541 34 56, ctsu.shapers@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: At 3 years after randomisation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052332, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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