Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07095439
PHASE2

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2023-09-01

Completion Date

2026-02-01

Last Updated

2025-07-31

Healthy Volunteers

No

Conditions

Interventions

RADIATION

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.

Locations (1)

Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams University

Cairo, Egypt