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

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ClinicalTrials.gov Identifier: NCT01064999
Recruitment Status : Unknown
Verified March 2012 by Zhen Zhang, Fudan University.
Recruitment status was:  Recruiting
First Posted : February 9, 2010
Last Update Posted : March 14, 2012
Sponsor:
Collaborators:
Zhejiang Cancer Hospital
First Affiliated Hospital of Zhejiang University
RenJi Hospital
Information provided by (Responsible Party):
Zhen Zhang, Fudan University

Tracking Information
First Submitted Date  ICMJE February 5, 2010
First Posted Date  ICMJE February 9, 2010
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
  • the rate of pathological complete response (pCR) [ Time Frame: within 14days after surgery ]
  • toxicity [ Time Frame: every week during radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
  • local recurrence [ Time Frame: every half year after surgery ]
  • disease-free survival [ Time Frame: every half year after surgery ]
  • overall survival [ Time Frame: every half year after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 8, 2010)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01064999
Other Study ID Numbers  ICMJE FDRT-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhen Zhang, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE
  • Zhejiang Cancer Hospital
  • First Affiliated Hospital of Zhejiang University
  • RenJi Hospital
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date March 2012

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