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Watchful Waiting for Rectal Cancer
Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether it's better to do surgery right away or wait and see if the tumor grows back before doing surgery in a selected group of patients.
Who is the study for?
This trial is for adults over 18 with rectal cancer that's close to the anal opening and hasn't spread far (stage T3/N0-N1M0). It includes those who have a slightly less advanced stage (low T2) but need major surgery. People under 18, with other cancers, or tumors farther from the anal verge or at different stages can't join.
What is being tested?
The study is testing 'watchful waiting' in patients at high risk of surgical complications. Instead of immediate radical surgery after local excision, doctors will closely monitor patients and only offer major surgery if the tumor starts growing again.
What are the potential side effects?
Since this approach avoids initial radical surgery, it may reduce surgical risks like wound problems. However, there's a chance that delayed treatment could impact long-term cancer control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Local recurrence free survival
Secondary study objectives
Quality of life using LARS score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Watchful WaitingExperimental Treatment1 Intervention
Six cycles of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin) will be administered every two weeks according to protocol. After a 3 week recovery period, this will be followed by conventional concurrent radiation and 5FU/capecitabine.
Patients will be re-staged two to three weeks after completion of induction FOLFOX therapy to ensure no disease progression. The patients will be re-staged again at least 7-11 weeks post completion of nCRT. Patients with restaging results showing either complete or near complete response, will be allocated to "watchful waiting."
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Who is running the clinical trial?
Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
32,393 Total Patients Enrolled
Amr Aref, MDPrincipal InvestigatorAscension St. John Hospital
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer is not in the stages mentioned before.I am under 18 years old.I have been diagnosed with another type of cancer.I have been diagnosed with rectal cancer.My tumor is at least 4 cm away from the anal opening.My tumor is located very close to the end of my bowel.I need a specific surgery for my low T2 cancer.My cancer is large but has not spread widely.
Research Study Groups:
This trial has the following groups:- Group 1: Watchful Waiting
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.