Neoadjuvant chemoradiotherapy and chemotherapy for rectal cancer
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
This study is testing if giving a combination of chemotherapy and radiation before surgery can help people with locally advanced rectal cancer do better than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Larissa University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Larissa) |
| Trial ID | NCT05496491 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of neoadjuvant chemoradiotherapy combined with consolidation chemotherapy before surgical resection against the standard treatment of neoadjuvant chemoradiotherapy followed by surgery and adjuvant chemotherapy in patients with rectal cancer. The study focuses on patients with locally advanced rectal cancer, specifically those with certain tumor characteristics. By administering both therapies preoperatively, the trial seeks to improve local control and reduce the risk of metastatic disease progression. The outcomes will be assessed to determine if this combined approach leads to better long-term survival rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with histologically confirmed rectal adenocarcinoma and specific tumor characteristics indicating the need for neoadjuvant treatment.
Not a fit: Patients with distant metastases, non-resectable cancer, or contraindications to chemotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced recurrence of rectal cancer for patients.
How similar studies have performed: Other studies have shown promising results with similar neoadjuvant approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Larissa
- Department of Surgery, University Hospital of Larissa — Larissa, Greece (Recruiting)
Study contacts
- Principal investigator: Konstantinos Perivoliotis, MD — University Hospital of Larissa
- Study coordinator: Konstantinos Perivoliotis, MD
- Email: kperi19@gmail.com
- Phone: 2413501000
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.