NCT07200141View on ClinicalTrials.gov

Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2028

Conditions
Locally Advanced Rectal Adenocarcinoma
Interventions
RADIATION

GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)

"Patients will receive neoadjuvant long course radiotherapy using VMAT or IMAT with daily image guided.~Gross tumor volume (GTV): A total dose of 58.75Gy delivered in 25 fractions using a simultaneous integrated boost approach; CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f ; Lateral lymph node（GTVnd2）：60Gy/25f;"

RADIATION

GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)

"Patients will receive neoadjuvant radiotherapy with GTV 50 Gy in 25 fractions , delivered with IMRT or VMAT technique.~CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f; Lateral lymph node（GTVnd2）"

DRUG

Concurrent Chemotherapy

Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy.

PROCEDURE

Total mesorectal excision (TME) surgery or non-operative management

"After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management (watch-and-wait) depending on response and clinical assessment."

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER