NCT05496491Recruiting
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 9 Aug 2022
- Start date
- 30 Aug 2022
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- Larissa University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05496491
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 30 Aug 2022 to the primary completion date, 30 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for the administration of chemotherapy
- Previous pelvic radiotherapy or chemotherapy
Other illness
- Non-resectable cancer
- History of inflammatory bowel disorders
- History of angina, acute myocardial infarction or heart failure
- Active sepsis or systemic infection
- Synchronous malignancy
Other
- Distant metastases
- Untreated physical and mental disability
- Pregnancy or breast-feeding
- Lack of compliance with the protocol process
- Non-granting of signed informed consent
Who the study is looking for
- Histologically confirmed rectal adenocarcinoma
- cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1
- Multidisciplinary tumor board decision for neoadjuvant treatment
- Tumor distance from the anal verge \<15 cm based on endoscopy or magnetic resonance imaging
- Patient 18 to 80 years old
- General health condition status WHO 0-1
- Absence of co-morbidities that may affect treatment
- Neutrophils \>1,500 / mm3, platelets \>100,000 / mm3, hemoglobin\> 10 g / dL, normal creatinine, and creatinine clearance\> 50 mL / min
- Signed informed consent of the patient
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Surgery, University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.