Sandwich total neoadjuvant treatment with short-course radiotherapy for stage II–III rectal cancer

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

This trial tests whether giving chemotherapy both before and after short-course radiotherapy (a 'sandwich' approach) is effective and safe for people with stage II–III rectal cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Ain Shams University (other)
• Drugs / interventions: chemotherapy, bevacizumab
• Locations: 1 site (Cairo)
• Trial ID: NCT07095439 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial delivers systemic chemotherapy before and after short-course radiotherapy (5x5 Gy) followed by planned surgery for patients with stage II–III rectal adenocarcinoma. The intent is to use the 'sandwich' sequencing to treat micrometastatic disease early and avoid delays in radiotherapy access while keeping overall treatment time short. Key outcomes include tumor response and treatment-related toxicity, with additional attention to surgical outcomes and short-term oncologic control. The design builds on recent randomized SCRT-based TNT approaches that showed similar or improved outcomes compared with long-course chemoradiotherapy.

Who should consider this trial

Good fit: Adults 18–70 years with pathologically confirmed low or mid rectal adenocarcinoma staged as II or III (T3 any N0 or T1-2 N+ M0) who are operable with ECOG 0–2 and meet basic blood and renal function criteria are ideal candidates.

Not a fit: Patients with metastatic disease, prior rectal cancer surgery, concurrent fistulising inflammatory bowel disease, surgical or medical inoperability, or those outside the age or lab criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve tumor control and reduce treatment delays and costs by combining short-course radiotherapy with systemic chemotherapy before and after radiation.

How similar studies have performed: Large randomized trials such as RAPIDO and Polish II have shown that SCRT-based total neoadjuvant strategies can improve oncologic outcomes with comparable toxicity, and this trial builds on those findings.

Eligibility criteria

Inclusion Criteria:

* · 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.

Exclusion Criteria:

* · 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 this trial is running

Cairo

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

Study contacts

• Principal investigator: Khaled M Abdel Karim, MD — Faculty of medicine, Ain Shams University
• Study coordinator: Hadeer H Mohamed, MSc

Conditions: Rectal Cancer, Rectal cancer, Short course radiotherapy, Total neoadjuvant treatment