Organ-preserving approach for rectal cancer after preoperative therapy
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
This study is trying to see if a watch-and-wait approach can help patients with rectal cancer keep their organs after treatment if their tumors respond well to pre-surgery therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 215 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Warsaw, Mazovian and 6 other locations) |
| Trial ID | NCT04095468 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of a watch-and-wait strategy for patients with rectal cancer who achieve a complete or near-complete tumor response following preoperative radio(chemo)therapy. It aims to define the proportion of patients experiencing clinical complete response (cCR) and identify predictive factors for cCR, particularly in cases of larger tumors. The study will involve a population-based cohort of patients with low rectal cancer, focusing on those who consent to the watch-and-wait approach or local excision. By analyzing outcomes, the study seeks to clarify the potential for organ preservation in rectal cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with primary low rectal cancer who have undergone routine preoperative radio(chemo)therapy and consent to a watch-and-wait strategy.
Not a fit: Patients with recurrent cancer, upper rectal tumors, or distant metastases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive treatment options and improved quality of life for rectal cancer patients.
How similar studies have performed: Other studies have shown promising results with similar watch-and-wait strategies in rectal cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary rectal cancer * Low tumour (accessible by digital rectal examination) * Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed. * Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR Exclusion Criteria: * Recurrent cancer * Cancers situated in the upper rectum * Distant metastases
Where this trial is running
Warsaw, Mazovian and 6 other locations
- Maria Skłodowska-Curie Institute - Oncology Center — Warsaw, Mazovian, Poland (Recruiting)
- Collegium Medicum Nicolaus Copernicus University and Oncology Centre — Bydgoszcz, Poland (Recruiting)
- Regional Oncological Centre — Kielce, Poland (Recruiting)
- Jagiellonian Medical University College — Kraków, Poland (Not_yet_recruiting)
- St. John's Cancer Center — Lublin, Poland (Recruiting)
- Silesian Oncological Centre — Wrocław, Poland (Recruiting)
- NU-MED Centre for Cancer Diagnosis and Treatment — Zamość, Poland (Recruiting)
Study contacts
- Study coordinator: Krzysztof Bujko, M.D. PhD
- Email: Krzysztof.Bujko@coi.pl
- Phone: +48601207466
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.