The purpose of this study is to determine whether adding deep hyperthermia to neoadjuvant concurrent radiochemotherapy could improve T-downstaging rate for locally advanced rectal cancer (LARC).
The purpose of this study is to determine whether adding deep hyperthermia to neoadjuvant concurrent radiochemotherapy could improve T-downstaging rate for locally advanced rectal cancer (LARC). The sample size is 142. Patients with LARC (T3-4/N+) will be randomly divided into intervention group and control group. For intervention group, the neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy. For control group, the neoadjuvant treatment is concurrent radiochemotherapy. T-downstaging rate will be used to evaluate the effectiveness of deep hyperthermia. T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Hyperthermia is a type of treatment in which tumor is heated to as high as 40.5-43℃ to help damage and kill cancer cells with little or no harm to normal tissue.
Tumor T-downstaging rate
T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.
Time frame: 12 weeks
Tumor shrinkage percentage
(tumor volume before treatment-tumor volume before neoadjuvant treatment) /( tumor volume before neoadjuvant treatment)
Time frame: 12 weeks
Complete tumor resection rate
(patient number of R0 resection)/(total number of patients undergoing surgery)
Time frame: 12 weeks
Pathological complete response rate
(number of patients with no residual tumors after neoadjuvant therapy)/(total number of patients undergoing surgery)
Time frame: 12 weeks
Perioperative complication rate
(number of patients with complications before or after surgery)/(total number of patients undergoing surgery)
Time frame: 4 months
Anal retention rate
(number of patients with anus preservation after surgery)/(total number of patients undergoing surgery)
Time frame: 12 weeks
Disease-free survival
the time from random day to disease progression or death (whichever occurs first);
Time frame: 3 year
Overall survival
the time between a random day and the day of death from any cause.
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Time frame: 3 year
36-Item Short-Form Health Survey(SF-36)
The minimum and maximum values of SF-36 are 30 and 150. Higher score means a better quality of life.
Time frame: 3 year
Quality of Life Questionnaire-Core 30(QLQ-C30)
The minimum and maximum values of QLQ-C30 are 0 and 100. Higher score means a better quality of life.
Time frame: 3year