[The optimult study concept - selective neoadjuvant chemoradiation therapy based on preoperative MRI]

Area of Science:

• Oncology
• Surgical Oncology
• Radiotherapy

Background:

• Total mesorectal excision (TME) is optimal for rectal cancer surgery, reducing local recurrence.
• Multimodal therapy improves outcomes for advanced rectal cancer, with neoadjuvant chemoradiation therapy (nCRT) common in Germany.
• Clinical staging for rectal cancer is often unreliable, leading to overtreatment and unnecessary side effects from nCRT.

Purpose of the Study:

• To evaluate if preoperative MRI can predict outcomes for rectal cancer patients.
• To determine if avoiding nCRT in patients with sufficient circumferential margins on MRI leads to non-inferior local recurrence rates compared to standard nCRT followed by surgery.
• To establish a basis for individualized rectal cancer therapy guided by preoperative MRI findings.

Main Methods:

• A two-armed randomized study comparing immediate surgery versus nCRT followed by surgery.
• Inclusion criteria: rectal cancer patients with ≥2 mm free circumferential margins on preoperative MRI.
• Primary endpoint: local recurrence rates in the intervention arm versus the control arm.

Main Results:

• (Study ongoing, results pending)

Conclusions:

• (Study ongoing, conclusions pending) Potential to avoid nCRT for select rectal cancer patients, reducing treatment burden and side effects.
• Preoperative MRI may play a crucial role in tailoring rectal cancer treatment strategies.
• This research could lead to more personalized and effective management of rectal cancer.