A groundbreaking clinical trial is underway to evaluate whether the addition of rosuvastatin to standard neoadjuvant chemoradiotherapy (NACTRT) can improve outcomes for patients with locally advanced rectal cancer. The prospective, randomized, open-label phase II/III study aims to build upon promising observational data suggesting statins may enhance treatment response.
The trial will randomize 316 patients between two treatment arms, with 158 patients in each group. The control arm will receive standard NACTRT, while the experimental arm will receive NACTRT plus rosuvastatin 20 mg daily for 6 weeks, followed by rosuvastatin alone for an additional 6-10 weeks until surgery.
Study Design and Endpoints
The primary endpoint focuses on pathologic complete response (pCR) rates, a crucial indicator of treatment success in rectal cancer. Secondary endpoints include:
- Adverse events assessment
- Postoperative morbidity and mortality
- Disease-free survival (DFS)
- Overall survival
- Identification of prognostic and predictive factors
Patient evaluation will occur through a multidisciplinary tumor board review 12-16 weeks after treatment initiation, following repeat imaging. The team will assess tumor regression grade (TRG) and document post-surgical complications for all operable patients.
Clinical Implications
This research represents a potentially significant advancement in rectal cancer treatment. If successful, the addition of rosuvastatin could offer several advantages:
- A low-cost intervention to improve treatment outcomes
- Minimal additional risk to patients
- Potential refinement of 'watch and wait' strategies for select patients
The study design includes a built-in pathway for progression to a phase III trial, which would evaluate 3-year disease-free survival as the primary endpoint, should the phase II results prove positive.
Treatment Protocol
The experimental arm's protocol consists of:
- Daily oral rosuvastatin (20 mg)
- Concurrent administration with standard NACTRT for 6 weeks
- Continued rosuvastatin monotherapy for 6-10 weeks pre-surgery
This carefully structured approach aims to maximize the potential benefits while maintaining patient safety and standard care protocols.
The trial represents a strategic approach to improving rectal cancer treatment outcomes through the repurposing of a well-established medication. Results could have significant implications for future treatment strategies and patient care protocols in oncology.
