NCT05496491 Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
| NCT ID | NCT05496491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Larissa University Hospital |
| Condition | Rectal Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-08-30 |
| Primary Completion | 2028-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2022-08-30 with a primary completion date of 2028-08-30.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Distant metastases * Non-resectable cancer * Contraindications for the administration of chemotherapy * Previous pelvic radiotherapy or chemotherapy * History of inflammatory bowel disorders * History of angina, acute myocardial infarction or heart failure * Active sepsis or systemic infection * Untreated physical and mental disability * Synchronous malignancy * Pregnancy or breast-feeding * Lack of compliance with the protocol process * Non-granting of signed informed consent
Contact & Investigator
Konstantinos Perivoliotis, MD
PRINCIPAL INVESTIGATOR
University Hospital of Larissa
Frequently Asked Questions
Who can join the NCT05496491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Rectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05496491 currently recruiting?
Yes, NCT05496491 is actively recruiting participants. Contact the research team at kperi19@gmail.com for enrollment information.
Where is the NCT05496491 trial being conducted?
This trial is being conducted at Larissa, Greece.
Who is sponsoring the NCT05496491 clinical trial?
NCT05496491 is sponsored by Larissa University Hospital. The principal investigator is Konstantinos Perivoliotis, MD at University Hospital of Larissa. The trial plans to enroll 84 participants.