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Chemotherapy and Local Excision for Colorectal Cancer

N/A
Recruiting
Led By Amr Aref, MD
Research Sponsored by Ascension South East Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Tumor in the low or mid rectum (up to 11 cm from the anal verge)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will test whether changes to the standard of care for rectal cancer can reduce the rate of distant recurrence and improve quality of life.

Who is the study for?
This trial is for adults over 18 with a specific type of rectal cancer (adenocarcinoma) located in the low or mid rectum. Candidates must not be pregnant, should have completed informed consent, and have a clinical stage T3/N0-N1M0 or some T2 cases requiring surgery.Check my eligibility
What is being tested?
The study tests if changing the timing and method of chemotherapy and radiation can reduce distant recurrence rates in rectal cancer patients while also using less invasive surgery when needed to improve quality of life.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection; radiation-related skin changes; and complications from less invasive surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My tumor is located in the lower or middle part of my rectum.
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I have been diagnosed with rectal cancer.
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My cancer stage was determined using a physical exam and various scans.
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My cancer is at a specific stage and hasn't spread far.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete remission
Disease progression
Local resection
+1 more
Secondary outcome measures
Patient health status
Patient quality of life

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Chemotherapy and Follow-up SurgeryExperimental Treatment1 Intervention
All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response.

Find a Location

Who is running the clinical trial?

Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
33,175 Total Patients Enrolled
Amr Aref, MDPrincipal Investigator - Ascension SME
Ascension South East Michigan
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Standard of care chemotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03941366 — N/A
Colorectal Cancer Research Study Groups: Neoadjuvant Chemotherapy and Follow-up Surgery
Colorectal Cancer Clinical Trial 2023: Standard of care chemotherapy Highlights & Side Effects. Trial Name: NCT03941366 — N/A
Standard of care chemotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03941366 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research study open to further recruitment?

"According to clinicaltrials.gov, the specified trial is actively recruiting volunteers; it was originally posted on February 26th 2016 and last adjusted on July 19th 2021."

Answered by AI

What criteria does one need to fulfill in order to be a suitable candidate for the clinical trial?

"The trial requires 15 adults aged between 18 and 95 to have adenocarcinoma, be in clinical stage T3/N0-N1M0 or lower that necessitates abdominal perineal resection, and pass the physical exam administered by their primary surgeon."

Answered by AI

How many participants are engaging in this research trial?

"Affirmative, as per clinicaltrials.gov's documentation, this trial is actively enlisting participants. It was first published on February 26th 2016 and updated on July 19th 2021. The experiment requires the recruitment of 15 subjects from 1 site."

Answered by AI

Does this trial accept individuals of an advanced age?

"To take part in this clinical trial, individuals must be between 18 and 95 years old. Separately, 12 studies are open for minors while 939 trials are accessible to those over the age of 65."

Answered by AI
~1 spots leftby Jan 2025