Watchful waiting approach for rectal cancer patients after therapy
Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (Fluorouracil / Capecitabine)-Radio Therapy (CRT) With Watchful Waiting for Complete Responders
This study is testing if a 'watchful waiting' approach can safely help rectal cancer patients who have responded well to treatment avoid surgery while still keeping their cancer under control and improving their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05526079 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a 'watchful waiting' strategy for patients with rectal cancer who have achieved a complete or near-complete clinical response after neo-adjuvant chemotherapy. The study aims to determine if this non-operative management approach can maintain local control and overall survival while improving patients' quality of life. Participants will undergo standard care assessments and additional imaging tests, with costs waived by providers. The trial focuses on a small cohort of patients at higher risk for complications, offering radical resection only if tumor regrowth occurs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with rectal invasive adenocarcinoma located within 4 cm of the anal verge and who have achieved a complete or near-complete clinical response after chemotherapy.
Not a fit: Patients with tumors larger than 4 cm from the anal verge or those with other forms of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgeries and improve the quality of life for rectal cancer patients.
How similar studies have performed: While the concept of watchful waiting is established in other cancers, this specific approach in rectal cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Detroit, Michigan
- Ascension St. John Hospital — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Amr Aref, MD — Ascension St. John Hospital
- Study coordinator: Amr Aref, MD
- Email: amr.aref@ascension.org
- Phone: (313) 647-3100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.