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
Phase 2/Phase 3
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Rectal Cancer
Both
Rectal Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the rate of pathological complete response (pCR)
Outcome Time Frame:
within 14days after surgery
Safety Issue:
No
Authority:
China: Ethics Committee
Study ID:
FDRT-002
NCT ID:
NCT01064999
Start Date:
March 2010
Completion Date:
December 2014
Related Keywords:
- Rectal Cancer
- Neoadjuvant chemotherapy
- locally advanced rectal cancer
- intensity-modulated radiation therapy
- pathological complete response
- Rectal Neoplasms
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