Testing short radiation with chemotherapy before and after rectal cancer treatment
Tests short-course radiation with chemotherapy before and after it in rectal cancer patients.
Plain-language title generated from the registry record
Registry title: Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
Key facts
- Where
- Cairo, EgyptSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07095439, who can take part
Where in Egypt
- Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams UniversityCairo, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ain Shams University
- Trial code
- NCT07095439
- Record updated
- 31 July 2025
- Original description
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.Read full original descriptionShow less
Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
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.
Inclusion: · 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: · 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.