Contact radiotherapy for rectal cancer (CORRECT): study protocol for a multicentre randomised phase II trial

Area of Science:

• Oncology
• Radiation Oncology
• Surgical Oncology

Background:

• Non-operative management is gaining traction for early rectal cancer.
• Contact X-ray brachytherapy (CXB) is an alternative to surgery for select cases.
• CXB combined with chemoradiotherapy (CRT) is established, but evidence for CXB with short-course radiotherapy (SCRT) is lacking.

Purpose of the Study:

• To compare the efficacy of CXB with CRT versus CXB with SCRT in patients with early-to-intermediate rectal cancer.
• To evaluate if CXB with SCRT is non-inferior to CXB with CRT regarding the 2-year organ preservation rate.
• To explore a new standard of care for organ preservation in rectal cancer, potentially avoiding surgery.

Main Methods:

• A Swedish national randomized phase II trial (CORRECT trial).
• 110 eligible patients with early-to-intermediate rectal cancer (cT1-cT3ab) were randomized into two arms.
• Arm A: CXB with CRT. Arm B: CXB with SCRT.

Main Results:

• The primary endpoint is the 2-year organ preservation rate.
• The study aims to demonstrate non-inferiority of CXB with SCRT compared to CXB with CRT.
• Oncological outcomes will be compared between the two treatment arms.

Conclusions:

• If non-inferiority is demonstrated, CXB with SCRT could become a new standard for organ preservation in early-to-intermediate rectal cancer.
• This approach offers a potential alternative to surgery for patients.
• The CORRECT trial will provide crucial randomized evidence for this treatment combination.