Clinical trial NCT01064999: A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
Official title: An Open Label, Randomized, Multi-center, Phase II/III Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy With Intensity-modified Radiation Therapy (IMRT) in Local Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rectal Cancer
Keywords: Neoadjuvant chemotherapy
locally advanced rectal cancer
intensity-modulated radiation therapy
pathological complete response
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: First People Hospital of Zhejiang
name: RenJi Hospital
First posted: 2010-02-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the rate of pathological complete response (pCR)
timeFrame: within 14days after surgery
measure: toxicity
timeFrame: every week during radiotherapy
Secondary outcomes:
measure: local recurrence
timeFrame: every half year after surgery
measure: disease-free survival
timeFrame: every half year after surgery
measure: overall survival
timeFrame: every half year after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital, Fudan University
state: Shanghai
Study officials:
References:
citation: Wang J, Guan Y, Gu W, Yan S, Zhou J, Huang D, Tong T, Li C, Cai S, Zhang Z, Zhu J. Long-course neoadjuvant chemoradiotherapy with versus without a concomitant boost in locally advanced rectal cancer: a randomized, multicenter, phase II trial (FDRT-002). Radiat Oncol. 2019 Nov 29;14(1):215. doi: 10.1186/s13014-019-1420-z.