Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rate
| Condition(s) | Rectal Cancer, Total Neoadjuvant Treatment, Neoadjuvant Therapy, Radiotherapy, Chemotherapy, Organ Preservation, Radiotherapy Side Effect, Chemotherapy Side Effects, Chemoradiotherapy, Low Anterior Re |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT. The study is divided into two parts: \*\*Part One:\*\* Participants with cT1N1, |
| Who can participate | Part One Inclusion Criteria: * Over 18 years of age. * Participants who agreed to participate in the study signed an informed consent form. * The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2. * Pathologically confirmed rectal adenocarcinoma. * Tumor up to 10 cm from the anus. * Magnetic resonance imaging (MRI) of the pelvis and computed tomography (CT) of the thorax and abdomen were performed to confirm the diagnosis. * cT1N1, T2-T3 N0 - 1, M0, MRF -, EMVI -. * Normal bone marrow function: blood leucocytes \> 3.5 × 10⁹/l, neutrophils \> 1.5 × 10⁹/l, platelets \> 100 × 10⁹/l. * Normal renal function: creatinine within 1,5 × normal. * Normal liver function: blood bilirubin levels within 1,5 times normal, AST, ALT levels within 2,5 times the upper limit. Exclusion Criter |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos |
| Locations | Vilnius, Lithuania |
| Start date | 2025-01-06 |
| NCT ID | NCT06758830 |
| Official listing | https://clinicaltrials.gov/study/NCT06758830 |