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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hadeer.h.mohamed20@gmail.com
• Phone: +201061214926

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.