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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local recurrence free survival

Secondary outcome measures

Quality of life using LARS score

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."

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ascension South East MichiganLead Sponsor

18 Previous Clinical Trials

32,494 Total Patients Enrolled

Amr Aref, MDPrincipal InvestigatorAscension St. John Hospital

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Watchful Waiting Clinical Trial Eligibility Overview. Trial Name: NCT05526079 — Phase 2

Colorectal Cancer Research Study Groups: Watchful Waiting

Colorectal Cancer Clinical Trial 2023: Watchful Waiting Highlights & Side Effects. Trial Name: NCT05526079 — Phase 2

Watchful Waiting 2023 Treatment Timeline for Medical Study. Trial Name: NCT05526079 — Phase 2

Frequently Asked Questions

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

Is the age range for participation in this medical experiment confined to people under 55?

"Participants that are above the age of consent and below 95 years old are eligible to take part in this medical trial."

Answered by AI

Has the FDA verified Watchfuf as a safe treatment option?

"We deem the safety of Watchfuf to be a score of 2 since it is in Phase 2 clinical trials, meaning there are preliminary data points supporting its security but no information regarding its efficacy."

Answered by AI

What is the upper limit on participants in this research endeavor?

"Affirmative. Per information published on clinicaltrials.gov, this research is currently recruiting participants. It was initially posted in July of 2018 and the last update was made August 30th 2022; 30 individuals need to be enrolled at 1 medical site."

Answered by AI

Is there a current opportunity for patients to participate in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov asserts that this research endeavour, which was initially posted on July 10th 2018, is actively recruiting participants. It requires 30 people to be enlisted from a single site."

Answered by AI

What criteria are necessary for someone to qualify as a participant in this trial?

"This clinical trial is seeking 30 participants for rectal adenocarcinoma treatment; the minimum age of eligibility is 18 years old and the maximum aged 95. To meet enrollment requirements, individuals must have a diagnosis of invasive adenocarcinoma in their lower rectum that lies within 4 cm from their anal verge as well as a T3/N0-N1M0 stage. Furthermore, those with low T2 who need abdominal perineal resection are also eligible to apply."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Amr Aref 2018. "Watchful Waiting for Complete Responders to Therapy in Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526079.