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Pre-operative Chemotherapy for Rectal Cancer (RAPIDO Trial)

Phase 3
Waitlist Available
Led By B. van Etten, MD, PhD
Research Sponsored by University Medical Center Groningen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically (T4a, i.e. overgrowth to an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side wall (according to TNM version 5), cT4b, i.e. peritoneal involvement, extramural vascular invasion (EMVI+). N2, i.e. four or more lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. Positive MRF, i.e. tumor or lymph node < 1 mm from the mesorectal fascia. Enlarged lateral nodes, > 1 cm (lat LN+)
Primary tumour characteristics: Histological proof of newly diagnosed primary adenocarcinoma of the rectum
Must not have
Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen
Known DPD deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether giving chemotherapy before surgery, instead of after, will improve survival rates for people with locally advanced rectal cancer.

Who is the study for?
This trial is for adults with newly diagnosed, high-risk rectal cancer that hasn't spread to distant parts of the body. Eligible patients must have certain tumor characteristics on MRI and can't be pregnant or breastfeeding, have uncontrolled medical conditions, significant heart disease, neuropathy symptoms, known malabsorption syndromes, or a history of other cancers within the last 5 years.
What is being tested?
The RAPIDO Trial is testing a new treatment approach against standard care in rectal cancer. Patients will either receive short-course radiotherapy followed by chemotherapy before surgery (M1 scheme) or the usual long course chemoradiotherapy before surgery. The goal is to improve survival rates by treating both local tumors and potential micro-metastases early.
What are the potential side effects?
Potential side effects include those common to radiation therapy such as skin irritation and fatigue; chemotherapy-related issues like nausea, vomiting, hair loss; surgical complications; and possibly increased risk of infections due to weakened immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, affecting nearby organs or has spread to many lymph nodes.
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My rectal cancer is newly diagnosed and confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has grown into the upper part of my sacrum or nerve roots, making surgery impossible.
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I have a known DPD deficiency.
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I have a serious heart condition or had a heart attack in the last year.
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I have a genetic condition like FAP or HNPCC, or active Crohn's disease or ulcerative colitis.
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I do not have any uncontrolled health conditions.
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I have had symptoms or a history of nerve damage in my hands or feet.
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My cancer has spread or my rectal tumor has come back.
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I have a condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease related Treatment Failure (DrTF)
Secondary study objectives
CRM negative rate
Overall survival
Quality of life LARS
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: B: 5x5Gy -> CAPOX -> surgeryExperimental Treatment1 Intervention
experimental group (arm B) M1 scheme
Group II: A: 5 weeks chemoradiation -> surgeryActive Control1 Intervention
control group (arm A) standard long course chemoradiotherapy

Find a Location

Who is running the clinical trial?

Leiden University Medical CenterOTHER
558 Previous Clinical Trials
606,375 Total Patients Enrolled
Karolinska University HospitalOTHER
497 Previous Clinical Trials
1,315,307 Total Patients Enrolled
Dutch Cancer SocietyOTHER
117 Previous Clinical Trials
76,666 Total Patients Enrolled
Uppsala University HospitalOTHER
180 Previous Clinical Trials
740,654 Total Patients Enrolled
University Medical Center GroningenLead Sponsor
756 Previous Clinical Trials
1,075,791 Total Patients Enrolled
B. van Etten, MD, PhDPrincipal InvestigatorUniversity Medical Center Groningen, Department of Surgery, Groningen, The Netherlands
B. Glimelius, MD, PhDPrincipal InvestigatorAkademiska Sjukhuset, Department of Oncology, Uppsala, Sweden
G. A. Hospers, MD, PhDPrincipal InvestigatorUniversity Medical Center Groningen, Department of Medical Oncology, Groningen, The Netherlands
1 Previous Clinical Trials
19 Total Patients Enrolled
C. J. van de Velde, MD, PhDPrincipal InvestigatorLeiden University Medical Center, Department of Surgery, Leiden, The Netherlands
C.A.M. Marijnen, MD, PhDPrincipal InvestigatorNetherlands Cancer Institute, Amsterdam, the Netherlands

Media Library

chemotherapy Clinical Trial Eligibility Overview. Trial Name: NCT01558921 — Phase 3
Colorectal Cancer Research Study Groups: A: 5 weeks chemoradiation -> surgery, B: 5x5Gy -> CAPOX -> surgery
Colorectal Cancer Clinical Trial 2023: chemotherapy Highlights & Side Effects. Trial Name: NCT01558921 — Phase 3
chemotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01558921 — Phase 3
~63 spots leftby Dec 2025
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