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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Capecitabine
Radiotherapy
Surgery
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Neoadjuvant chemotherapy, locally advanced rectal cancer, intensity-modulated radiation therapy, pathological complete response

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity group

Low instensity group

Arm Description

(RT 55Gy + CapOx) + a cycle of Xelox + Surgery

(RT 50Gy + CapOx) + Surgery

Outcomes

Primary Outcome Measures

the rate of pathological complete response (pCR)
toxicity

Secondary Outcome Measures

local recurrence
disease-free survival
overall survival

Full Information

First Posted
February 5, 2010
Last Updated
March 12, 2012
Sponsor
Fudan University
Collaborators
Zhejiang Cancer Hospital, First People Hospital of Zhejiang, RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01064999
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Zhejiang Cancer Hospital, First People Hospital of Zhejiang, RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Neoadjuvant chemotherapy, locally advanced rectal cancer, intensity-modulated radiation therapy, pathological complete response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity group
Arm Type
Experimental
Arm Description
(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
Arm Title
Low instensity group
Arm Type
Active Comparator
Arm Description
(RT 50Gy + CapOx) + Surgery
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
CRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
High intensity group:55Gy Low intensity group:50Gy
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Lower anterior resection or abdominoperineal resection
Primary Outcome Measure Information:
Title
the rate of pathological complete response (pCR)
Time Frame
within 14days after surgery
Title
toxicity
Time Frame
every week during radiotherapy
Secondary Outcome Measure Information:
Title
local recurrence
Time Frame
every half year after surgery
Title
disease-free survival
Time Frame
every half year after surgery
Title
overall survival
Time Frame
every half year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Zhu, MD
Email
leo.zhu@126.com
Facility Information:
Facility Name
Cancer Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, MD
First Name & Middle Initial & Last Name & Degree
Ji Zhu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31783766
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.
Results Reference
derived

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

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