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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• · 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.

Locations
Other Locations
Egypt
Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams University
RECRUITING
Cairo
Contact Information
Primary
Hadeer H Mohamed, MSc
hadeer.h.mohamed20@gmail.com
+201061214926
Backup
Sara E Zaki, MD
sara.zaki@med.asu.edu.eg
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 38
Treatments
Experimental: Total neoadjuvant treatment via short course radiotherapy
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.
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov

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