Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

Launched by LARISSA UNIVERSITY HOSPITAL · Aug 9, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment approaches for patients with rectal cancer. The first approach combines chemotherapy and radiation therapy before surgery, followed by more chemotherapy after surgery. The second approach is the standard treatment, which involves chemotherapy and radiation before surgery, and then additional chemotherapy afterward. The goal is to see which method is more effective in treating rectal cancer.

To participate in this trial, patients must be between 18 and 80 years old and have a specific type of rectal cancer that hasn’t spread to other parts of the body. They should be in good overall health and meet certain blood test requirements. The trial is currently recruiting participants, and those who join will receive close monitoring throughout the treatment process. It’s important for potential participants to discuss with their doctors whether this trial is a suitable option for them.

Gender

ALL

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