Efficacy and Safety of Short-course Radiotherapy (SCRT) Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Procedure, Combination product, Drug, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Age ≥ 70 years old

• ECOG performance status (PS):

‣ ≤1 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.

Locations
Other Locations
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
ZAS Antwerpen
RECRUITING
Antwerp
Chirec Delta
RECRUITING
Auderghem
CHU Brugmann
RECRUITING
Brussels
CHU Saint-Pierre
RECRUITING
Brussels
CHU Charleroi
NOT_YET_RECRUITING
Charleroi
Grand Hôpital De Charleroi
SUSPENDED
Charleroi
UZA Antwerpen
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
CHU UCL Namur
RECRUITING
Godinne
Hôpital de Jolimont
RECRUITING
Haine-saint-paul
Epicura
RECRUITING
Hornu
CHA Libramont
RECRUITING
Libramont
CHU de Liège - Sart Tilman
RECRUITING
Liège
CHU Ambroise Pare
NOT_YET_RECRUITING
Mons
CHR Sambre et Meuse (site Meuse)
NOT_YET_RECRUITING
Namur
CHU St Elisabeth
RECRUITING
Namur
AZ Nikolaas
RECRUITING
Sint-niklaas
AZ Turnhout
RECRUITING
Turnhout
Contact Information
Primary
Tabatha Delsaute
ctsu.shapers@hubruxelles.be
+32 (0)2 541 36 62
Backup
Laurène Huberty
ctsu.shapers@hubruxelles.be
+32 (0)2 541 73 76
Time Frame
Start Date: 2024-02-07
Estimated Completion Date: 2033-12
Participants
Target number of participants: 230
Treatments
Experimental: SCRT arm
* SCRT (5 fractions of 5 Gy)~* Surgery (according to the principle of TME) or watch \& wait~* Optional adjuvant chemotherapy
Active_comparator: TNT arm
Rapido 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
Related Therapeutic Areas
Sponsors
Leads: Jules Bordet Institute

This content was sourced from clinicaltrials.gov