OncoMatch/Clinical Trials/NCT07095439
Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
Is NCT07095439 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for rectal cancer.
Several trials showed that total neoadjuvant treatment (TNT) in stage II/III rectal cancer patients had better outcomes when compared with standard neoadjuvant long-course radiotherapy (CRT). Recently, based on the RAPIDO and POLISH II trials a short course radiotherapy (SCRT)-including TNT strategy had better oncologic outcomes and comparable toxicities. Moreover, cost-effectively, an SCRT-including TNT strategy is more convenient than a CRT-based TNT approach. In addition, systemic chemotherapy is often used to treat occult or micrometastatic disease in intermediate and locally advanced rectal cancer. However, the timing of chemotherapy delivery remains a topic of debate. In this context, and since rapid access to radiotherapy treatment is limited, especially in developing countries, a TNT strategy whereby adjuvant chemotherapy is replaced by systemic chemotherapy delivered before and after SCRT according to a "sandwich" treatment can avoid delays in treatment start with equivalent outcomes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III, T3 N ANY M0, T1-2 N+VE M0
Stage II and stage III by imaging (T3 N any M0 or T1-2 N+ve M0) [29]; staged with MRI rectal protocol or EUS.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: surgical treatment for rectal cancer
Previous surgical treatment for rectal cancer
Cannot have received: pelvic radiotherapy
Previous pelvic radiotherapy
Lab requirements
Blood counts
absolute neutrophilic count of 1.5 × 10⁹ cells per l or higher, platelet count of 100 × 10⁹ per l or higher, a clinically acceptable haemoglobin level
Kidney function
creatinine level indicating renal clearance of 50 ml/min or higher
Liver function
bilirubin level below 2 mg/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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