Actively Recruiting
Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
Led by Ain Shams University · Updated on 2025-07-31
38
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or III rectal cancer by imaging (T3 N any M0 or T1-2 N+ve M0) staged with MRI rectal protocol or EUS.
- Disease staged with CT imaging of chest, abdomen, and pelvis before treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Laboratory results including absolute neutrophilic count ≥ 1.5 x 10⁹ cells/L, platelet count ≥ 100 x 10⁹/L, acceptable hemoglobin level, creatinine clearance ≥ 50 mL/min, and bilirubin level below 2 mg/dL.
- Written informed consent.
You will not qualify if you...
- 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.
- Diseases preventing chemotherapy or radiotherapy such as grade 3 neuropathy or severe cardiovascular disease.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams University
Cairo, Egypt, 1181
Actively Recruiting
Research Team
H
Hadeer H Mohamed, MSc
CONTACT
S
Sara E Zaki, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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