UNICANCER Initiates Phase 3 Trial to Investigate Treatment Strategies for Elderly Patients with Locally Advanced Rectal Cancer

A clinical trial, NACRE-2, has been launched by UNICANCER to evaluate the effectiveness of two treatment strategies for elderly patients with locally advanced rectal cancer. The trial aims to assess whether the addition of chemotherapy after short-course radiotherapy is more effective than short-course radiotherapy alone in this patient population. The trial is currently in its Phase 3 stage and has a sample size of 160 participants from the USA.

Key Takeaways:

• The primary objective of the NACRE-2 trial is to compare the efficacy of chemotherapy plus short-course radiotherapy with short-course radiotherapy alone in elderly patients with locally advanced rectal cancer.
• The trial will assess the efficacy and safety profile of the combination of chemotherapy and short-course radiotherapy.
• Patients will be separated into two groups: one receiving chemotherapy and short-course radiotherapy, and the other receiving short-course radiotherapy alone.
• The trial will involve a radiological assessment of the disease 11 weeks after the end of radiotherapy.
• Patients whose tumors have shrunk will not undergo surgery, and will enter a surveillance phase.
• Patients whose tumors are still present will undergo surgery and enter the follow-up phase.
• The trial will last for a maximum duration of 3 years.

Statistics:

• The trial has a sample size of 160 participants from the USA.
• The trial will assess the efficacy and safety profile of the combination of chemotherapy and short-course radiotherapy.
• The primary objective of the trial is to compare the efficacy of chemotherapy plus short-course radiotherapy with short-course radiotherapy alone in elderly patients with locally advanced rectal cancer.
• The trial will involve a radiological assessment of the disease 11 weeks after the end of radiotherapy.

Sources:

• ClinicalTrials.gov

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