Rectal Cancer
Conditions
Keywords
Neoadjuvant chemotherapy, locally advanced rectal cancer, intensity-modulated radiation therapy, pathological complete response
Brief summary
Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.
Interventions
DRUGOxaliplatin
CRT:50mg/m2,IV,weekly\*5 cycle CT: 130mg/m2,IV,d1,q 21 day
DRUGCapecitabine
CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
RADIATIONRadiotherapy
High intensity group:55Gy Low intensity group:50Gy
PROCEDURESurgery
Lower anterior resection or abdominoperineal resection
Sponsors
Zhejiang Cancer Hospital
First People Hospital of Zhejiang
RenJi Hospital
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with rectal adenocarcinoma * Clinical staged T3/4 or any node-positive disease * Age: 18-75 years * Karnofsky Performance Status \> 80 * Adequate bone marrow reserve, renal and hepatic functions * Without previous antitumoural chemotherapy * No evidence of metastatic disease * Written informed consent before randomization
Exclusion criteria
* Previous pelvis radiotherapy. * Previous antitumoural chemotherapy * Clinically significant internal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of pathological complete response (pCR) | within 14days after surgery |
| toxicity | every week during radiotherapy |
Secondary
| Measure | Time frame |
|---|---|
| local recurrence | every half year after surgery |
| disease-free survival | every half year after surgery |
| overall survival | every half year after surgery |
Countries
China
Contacts
Primary ContactJi Zhu, MD
Outcome results
None listed