Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients

Recruiting now · Phase 2

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT07095439

Run by

Ain Shams University

People needed

38

Starts

2023-09-01

Expected to finish

2026-02-01

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• · Patients aged 18 years old till 70 years old.
• Pathologically confirmed rectal adenocarcinoma of low or mid rectum (less than 16 cm from the anal verge on endoscopy)
• 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.
• The disease was staged with CT imaging of chest, abdomen and pelvis pretreatment.
• Eastern Cooperative Oncology Group (ECOG) performance status= 0-2.
• The following laboratory results are required: 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, a creatinine level indicating renal clearance of 50 mL/min or higher, and bilirubin level below 2 mg/dL.
• Written informed consent.

You may not qualify if…

• · Previous surgical treatment for rectal cancer or concurrent fistulising inflammatory bowel disease of the rectum.
• Surgical or medical inoperability.
• Previous pelvic radiotherapy.
• Second malignancy within the last 5 years.
• Patients with diseases that do not allow receipt of chemotherapy or radiotherapy as grade 3 neuropathy and severe cardiovascular disease.

Where it is running

• Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams University — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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