RecruitingNot ApplicableNCT06052332

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

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

Sponsor

Jules Bordet Institute

Enrollment

230 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

Older People Locally Advanced Rectal Cancer

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

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two pre-surgery treatment strategies for older adults with locally advanced rectal cancer: standard neoadjuvant therapy (chemoradiation before surgery) versus total neoadjuvant therapy (all chemotherapy and radiation given before surgery, with no post-surgery chemotherapy). The goal is to find what works best for patients aged 70 and over. **You may be eligible if...** - You are 70 or older - You have rectal cancer confirmed by biopsy that is in stage II (high-risk) or stage III - The tumor is in the lower portion of the rectum (within 15 cm of the anal opening) - Your blood counts and organ function are within acceptable levels - You are in good enough health to receive treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had prior radiation therapy to the pelvis - You have severe heart, kidney, or liver disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONShort course radiotherapy

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

DRUGAdjuvant chemotherapy (optional)

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

PROCEDURETotal mesorectal excision

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.

COMBINATION_PRODUCTTotal neoadjuvant therapy

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)

RADIATIONLong course chemoradiotherapy

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

Locations(19)

ZAS Antwerpen

Antwerp, Antwerpen, Belgium

UZA Antwerpen

Edegem, Antwerpen, Belgium

AZ Turnhout

Turnhout, Antwerpen, Belgium

Institut Jules Bordet

Anderlecht, Brussels Capital, Belgium

Chirec Delta

Auderghem, Brussels Capital, Belgium

CHU Saint-Pierre

Brussels, Brussels Capital, Belgium

CHU Brugmann

Brussels, Brussels Capital, Belgium

UZ Gent

Ghent, East Flanders, Belgium

AZ Nikolaas

Sint-Niklaas, East Flanders, Belgium

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, Belgium

Epicura

Hornu, Hainaut, Belgium

CHU Ambroise Pare

Mons, Hainaut, Belgium

CHU de Liège - Sart Tilman

Liège, Liège, Belgium

CHA Libramont

Libramont, Luxemburg, Belgium

Grand Hôpital De Charleroi

Charleroi, Namur, Belgium

CHU Charleroi

Charleroi, Namur, Belgium

CHU UCL Namur

Godinne, Namur, Belgium

CHR Sambre et Meuse (site Meuse)

Namur, Namur, Belgium

CHU St Elisabeth

Namur, Namur, Belgium

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NCT06052332

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