Trial results for the RAPIDO trial, investigating treatment strategies for Rectal Cancer, were posted on ClinicalTrials.gov on 2026-05-01. The study found a statistically significant reduction in disease-related treatment failure (DrTF) with a p-value of 0.05. Specifically, 128 participants in the experimental arm experienced DrTF, compared to 152 participants in the standard treatment arm.
Background
Currently, the 3-year disease-free survival for patients with locally advanced rectal cancer is approximately 50%. The established standard treatment for patients at high risk of local and/or systemic failure involves pre-operative long-course radiotherapy (5 weeks) combined with chemotherapy, known as neoadjuvant chemoradiotherapy. While this neoadjuvant approach has been shown to improve local control, it has not demonstrated an effect on overall survival. Furthermore, various studies investigating the impact of adjuvant post-operative chemotherapy in rectal cancer patients have not resulted in an improved survi.
Trial design
The RAPIDO trial (NCT01558921) is a PHASE3 study that enrolled 920 participants with Rectal Cancer. The trial compared two neoadjuvant treatment strategies followed by surgery. The experimental arm (Group B) received 5x5Gy radiotherapy followed by CAPOX chemotherapy and then surgery. The comparator arm (Group A) received 5 weeks of chemoradiation followed by surgery. The primary outcome for analysis was the 3-year cumulative probability of disease-related treatment failure.
Key results
The primary outcome, Number of Patients With Disease Related Treatment Failure (DrTF), showed a notable difference between the two groups:
- In the experimental arm (B: 5x5Gy -> CAPOX -> Surgery), 128 participants experienced disease-related treatment failure.
- In the standard arm (A: 5 Weeks Chemoradiation -> Surgery), 152 participants experienced disease-related treatment failure.
A statistical analysis using a Log Rank test yielded a p-value of 0.05, indicating a statistically significant difference in disease-related treatment failure between the two treatment groups.
Regarding treatment completion:
- In the experimental arm (B: 5x5Gy -> CAPOX -> Surgery), 386 participants completed the prescribed neo-adjuvant treatment dose.
- In the standard arm (A: 5 Weeks Chemoradiation -> Surgery), 410 participants completed the prescribed neo-adjuvant treatment dose.
For the outcome of Negative Circumferential Resection Margin (CRM Negative):
- In the experimental arm (B: 5x5Gy -> CAPOX -> Surgery), 385 participants achieved a negative CRM.
- In the standard arm (A: 5 Weeks Chemoradiation -> Surgery), 363 participants achieved a negative CRM.
What this means
The results of the RAPIDO trial suggest that the neoadjuvant regimen of 5x5Gy radiotherapy followed by CAPOX chemotherapy and surgery may be a more effective strategy for reducing disease-related treatment failure in patients with locally advanced rectal cancer compared to the current standard of 5 weeks of chemoradiation followed by surgery. The statistically significant p-value of 0.05 supports the potential benefit of this novel approach, which could lead to improved outcomes for patients with this challenging condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT01558921, titled "Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial," were posted on 2026-05-01 on clinicaltrials.gov.