Chemotherapy and Local Excision for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAmr Aref, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Henry Ford Health System

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if giving rectal cancer patients a specific chemotherapy before surgery can improve their quality of life and reduce cancer recurrence. The goal is to see if this approach can help patients avoid more invasive surgeries and achieve better overall results.

Research Team

Amr Aref, MD

Principal Investigator

Ascension SME

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My tumor is located in the lower or middle part of my rectum.

I have been diagnosed with rectal cancer.

See 2 more

Exclusion Criteria

Do not complete informed consent

You are pregnant.

I am under 18 years old.

Treatment Details

Interventions

Standard of care chemotherapy (Chemotherapy)
Transanal Local Excision (Procedure)

Trial OverviewThe 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.

Participant Groups

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.