NCT05526079 Watchful Waiting for Complete Responders to Therapy in Rectal Cancer
| NCT ID | NCT05526079 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henry Ford Health System |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-07-10 |
| Primary Completion | 2028-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2018-07-10 with a primary completion date of 2028-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this project is to determine if in a selected group of patients, at higher risk of wound dehiscence and other complications, treatment by local excision and management by a "watchful waiting" or an initial "non-operative management" approach, with an offer of radical resection only to those patients whose tumors demonstrate "regrowth" will maintain acceptable local control and overall survival rate for the whole cohort.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Diagnosis of rectal invasive adenocarcinoma 3. Tumor in the low rectum lying \< 4 cm from the anal verge 4. Clinical stage T3/N0-N1M0. 5. Patients with low T2 who will need abdominal perineal resection are also eligible. Exclusion Criteria: 1. Age less than 18 years 2. Other forms of cancer 3. Tumors \>= 4 cm from the anal verge 4. Tumors of other clinical stages than listed above
Contact & Investigator
Amr Aref, MD
PRINCIPAL INVESTIGATOR
Ascension St. John Hospital
Frequently Asked Questions
Who can join the NCT05526079 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05526079 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05526079 currently recruiting?
Yes, NCT05526079 is actively recruiting participants. Contact the research team at amr.aref@ascension.org for enrollment information.
Where is the NCT05526079 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05526079 clinical trial?
NCT05526079 is sponsored by Henry Ford Health System. The principal investigator is Amr Aref, MD at Ascension St. John Hospital. The trial plans to enroll 30 participants.
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