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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 year
Awards & highlights
RAPIDO Trial 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.Check my eligibility
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.See study design
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.
RAPIDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, affecting nearby organs or has spread to many lymph nodes.
Select...
My rectal cancer is newly diagnosed and confirmed by a biopsy.
RAPIDO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease related Treatment Failure (DrTF)
Secondary outcome measures
CRM negative rate
Overall survival
Quality of life LARS
+6 moreRAPIDO 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?
University Medical Center GroningenLead Sponsor
703 Previous Clinical Trials
654,538 Total Patients Enrolled
Karolinska University HospitalOTHER
473 Previous Clinical Trials
1,303,705 Total Patients Enrolled
Leiden University Medical CenterOTHER
520 Previous Clinical Trials
467,070 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has grown into the upper part of my sacrum or nerve roots, making surgery impossible.I have a known DPD deficiency.My cancer is advanced, affecting nearby organs or has spread to many lymph nodes.I have a serious heart condition or had a heart attack in the last year.I have a genetic condition like FAP or HNPCC, or active Crohn's disease or ulcerative colitis.I do not have any uncontrolled health conditions.I have no other cancers except for treated skin or cervical cancer, and have been cancer-free for 5 years.You have received any experimental treatment for rectal cancer within the last month.You are pregnant or breastfeeding.My rectal cancer is newly diagnosed and confirmed by a biopsy.I have had symptoms or a history of nerve damage in my hands or feet.My cancer has spread or my rectal tumor has come back.I have a condition that affects how my body absorbs nutrients.
Research Study Groups:
This trial has the following groups:- Group 1: B: 5x5Gy -> CAPOX -> surgery
- Group 2: A: 5 weeks chemoradiation -> surgery
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions left in this research project?
"Unfortunately, this particular clinical trial is not enrolling patients at the current moment. Although the study was posted over a decade ago on June 21st, 2011 and edited as recently as June 24th, 2022; there are other medical trials with open enrollment that potential participants can investigate."
Answered by AI
Does the M1 scheme have FDA backing?
"M1 scheme is backed by safety data from multiple Phase 3 trials, meaning it received a score of 3."
Answered by AI
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