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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.
Verified March 2012 by Fudan University
Sponsor:
Collaborators:
Zhejiang Cancer Hospital
First People Hospital of Zhejiang
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
 Drug: Oxaliplatin
Drug: Capecitabine
Radiation: Radiotherapy
Procedure: Surgery
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High intensity group
(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
 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
Active Comparator: Low instensity group
(RT 50Gy + CapOx) + Surgery
 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064999

Contacts
Contact: Ji Zhu, MD leo.zhu@126.com

Locations
China, Shanghai
Cancer Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Principal Investigator: Zhen Zhang, MD            
Sub-Investigator: Ji Zhu, MD            
Sponsors and Collaborators
Fudan University
Zhejiang Cancer Hospital
First People Hospital of Zhejiang
RenJi Hospital
  More Information

No publications provided

Responsible Party: Zhen Zhang, Division Head, Division of Radiation Oncology,Cancer Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01064999     History of Changes
Other Study ID Numbers: FDRT-002
Study First Received: February 5, 2010
Last Updated: March 12, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Neoadjuvant chemotherapy
locally advanced rectal cancer
intensity-modulated radiation therapy
pathological complete response

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
 Rectal Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013