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Anti-metabolites
Chemotherapy for Early Rectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient must have an ECOG performance status of 0, 1
Tumour stage cT1-T3abN0 based on pelvic MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will test if chemotherapy can make less invasive surgery possible for people with early rectal cancer.
Who is the study for?
This trial is for adults with early-stage rectal cancer, confirmed by biopsy and MRI, who haven't had previous treatment or pelvic radiation. They must be fit for surgery, have no other cancers (with some exceptions), and not be on other investigational drugs. Participants need functioning organs, no serious heart conditions, and agree to use contraception.Check my eligibility
What is being tested?
The NEO trial tests if chemotherapy (Folfox or Capox) followed by less invasive surgery can allow patients to keep their rectum. It's considered successful if at least 65% of participants maintain rectal function post-treatment.See study design
What are the potential side effects?
Possible side effects from Folfox or Capox chemotherapy may include nausea, fatigue, nerve damage like tingling in hands/feet (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems, diarrhea, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer is in an early to mid-stage, according to my MRI results.
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My cancer has not spread beyond the first layers of muscle near the rectum and shows no signs of spreading to nearby lymph nodes.
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I can safely receive the chemotherapy outlined in the study.
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I am 18 years old or older.
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My cancer has not spread to other parts of my body, as confirmed by a CT scan.
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My kidneys are functioning well, with a creatinine clearance of 50 ml/min or more.
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My tumor has grown into the muscle layer but hasn't spread to nearby lymph nodes or blood vessels.
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My tumor is in the early stage and hasn't spread to lymph nodes or blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of organ preservation rate
Secondary outcome measures
Cost effectiveness using the EQ-5D-5L questionnaire
Disease Free Survival (DFS) estimated based on Kaplan-Meier method
Distant Relapse Rate (DRR) estimated based on Kaplan-Meier method
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: chemotherapy (FOLFOX or CAPOX) followed by tumour excisionExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folfox Protocol
2015
Completed Phase 3
~680
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,395 Total Patients Enrolled
Hagen KenneckeStudy ChairVirginia Mason Medical Centre, WA USA
1 Previous Clinical Trials
250 Total Patients Enrolled
Carl BrownStudy ChairSt. Paul's Hospital, Vancouver BC
3 Previous Clinical Trials
306 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to other parts of my body, as confirmed by a CT scan.My surgeon believes I am fit for major surgery.My recent tests show my organs and bone marrow are functioning well.I am fully active or can carry out light work.I agree to use effective birth control during and for 6 months after chemotherapy.I can and will fill out the quality of life surveys.I am fully active or restricted in physically strenuous activity but can do light work.I have had cancer before, but it was either skin cancer treated fully, cervical cancer treated without spreading, or any cancer treated over 5 years ago with no current signs of disease.I have more than one type of cancer at the same time.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I have had radiation therapy in the pelvic area before.My cancer is in an early to mid-stage, according to my MRI results.I have received treatment for rectal cancer before.I haven't taken any experimental drugs or cancer treatments in the last 28 days.My cancer has not spread beyond the first layers of muscle near the rectum and shows no signs of spreading to nearby lymph nodes.I can safely receive the chemotherapy outlined in the study.I am 18 years old or older.My cancer has not spread to other parts of my body, as confirmed by a CT scan.My tumor is in a position where it can be surgically removed.My kidneys are functioning well, with a creatinine clearance of 50 ml/min or more.I am 18 years old or older.I agree to use effective birth control during and for 6 months after chemotherapy.My rectal cancer is confirmed by a biopsy, even if not seen on MRI.My tumor has grown into the muscle layer but hasn't spread to nearby lymph nodes or blood vessels.My cancer has not spread beyond the first layers of muscle near the rectum and shows no signs of spreading to nearby lymph nodes.My kidneys are functioning well.My rectal cancer was confirmed by a lab test and is not poorly differentiated.I can and will complete the quality of life surveys.My tumor can be removed with surgery, according to my surgeon.My tumor has grown into the muscle layer but hasn't spread to nearby lymph nodes or blood vessels.My tumor is in the early stage and hasn't spread to lymph nodes or blood vessels.I have had a serious heart condition or stroke in the last 6 months.My rectal cancer was confirmed by a lab test within the last 3 months.My rectal cancer is confirmed by biopsy, even if not seen on MRI.My tumor is in the early stage and has not spread to lymph nodes or blood vessels.My biopsy shows high-risk cancer features.
Research Study Groups:
This trial has the following groups:- Group 1: chemotherapy (FOLFOX or CAPOX) followed by tumour excision
Awards:
This trial has 1 awards, including:- 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.
Does the Folfox Protocol have regulatory approval?
"Though there is limited evidence indicating Folfox Protocol's efficacy, the available data regarding safety warrants a score of 2."
Answered by AI
What is the current scope of medical facilities hosting this trial?
"Currently, 11 medical centres across the continent are enrolling patients for this study. Sites include Health Sciences North in Sudbury, CancerCare Manitoba in Winnipeg and Dana-Farber Cancer Institute in Boston among others."
Answered by AI
Are there any opportunities for participants to join this research endeavor?
"This medical investigation, which was first posted on August 22nd 2017, is no longer recruiting participants. However, 339 other trials are currently collecting patients to join their research initiatives."
Answered by AI
Who else is applying?
What site did they apply to?
Virginia Mason Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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