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

NCT06052332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer
  • Older People

Interventions

RADIATION

Short course radiotherapy

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

DRUG

Adjuvant chemotherapy (optional)

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

PROCEDURE

Total 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_PRODUCT

Total 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)

RADIATION

Long 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

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Francesco Sclafani · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2029-12-31
Completion
2033-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052332 on ClinicalTrials.gov