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

NCT07095439 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Phase 2

Started

2023-09-01

Last updated

2025-07-31

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Total Neoadjuvant Treatment

Total Neoadjuvant Treatment: Participants in this arm receive 4 cycles of induction chemotherapy CAPEOX (or 5 cycles of FOLFOX6), followed by short course radiotherapy (25 Gy in 5 fractions) delivered via IMRT technique ,then consolidation chemotherapy in the form of : 2 cycles of CAPOX (or, 4 cycles of FOLFOX6). Total mesorectal excision (TME) will be performed for non-metastatic patients within 8-12 weeks of the short course radiotherapy.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Pathological complete response — 6 months, from induction chemotherapy till total mesorectal excision
The complete disappearance of all signs of cancer in tissue samples after treatment with chemotherapy and radiation therapy.

Trial sites (1)

Facility	City	Region	Status
Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams University	Cairo	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07095439 on ClinicalTrials.gov ↗ ← All trials in Egypt