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A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Fudan University
Sponsor:
Collaborators:
Zhejiang Cancer Hospital
First Affiliated Hospital of Zhejiang University
RenJi Hospital
Information provided by (Responsible Party):
Zhen Zhang, Fudan University
ClinicalTrials.gov Identifier:
NCT01064999
First received: February 5, 2010
Last updated: March 12, 2012
Last verified: March 2012

February 5, 2010
March 12, 2012
March 2010
March 2012   (final data collection date for primary outcome measure)
  • the rate of pathological complete response (pCR) [ Time Frame: within 14days after surgery ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: every week during radiotherapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01064999 on ClinicalTrials.gov Archive Site
  • local recurrence [ Time Frame: every half year after surgery ] [ Designated as safety issue: No ]
  • disease-free survival [ Time Frame: every half year after surgery ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: every half year after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • Drug: Oxaliplatin
    CRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day
  • Drug: Capecitabine
    CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
  • Radiation: Radiotherapy
    High intensity group:55Gy Low intensity group:50Gy
  • Procedure: Surgery
    Lower anterior resection or abdominoperineal resection
  • Experimental: High intensity group
    (RT 55Gy + CapOx) + a cycle of Xelox + Surgery
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
    • Radiation: Radiotherapy
    • Procedure: Surgery
  • Active Comparator: Low instensity group
    (RT 50Gy + CapOx) + Surgery
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
    • Radiation: Radiotherapy
    • Procedure: Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2014
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Ji Zhu, MD leo.zhu@126.com
China
 
NCT01064999
FDRT-002
Yes
Zhen Zhang, Fudan University
Fudan University
  • Zhejiang Cancer Hospital
  • First Affiliated Hospital of Zhejiang University
  • RenJi Hospital
Not Provided
Fudan University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP