The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are: * Is total neoadjuvant treatment in this design safe \& tolerable? * Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery
National Cancer Institute
Cairo, الجيزة, Egypt
pathological complete response (pCR)
No residual disease in surgical specimen
Time frame: within 30 days
clinical complete response(cCR)
No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy
Time frame: within 30 days
Sphincter saving surgery
Patients who were deemed abdomino-perineal resection before treatment start \& were able to undergo low anterior resection after end of treatment
Time frame: within 6 months
Local control
defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.
Time frame: 3 years
Overall survival
defined as period from diagnosis till last follow up or death from any cause
Time frame: 3 years
Disease free survival
defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure or distant failure, whichever comes first.
Time frame: within 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.