Back to resultsNimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Primary Purpose
Locally Advanced Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Preoperative irradiation
Nimotuzumab
Oxaliplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Nimotuzumab
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Age:18-75 years
- Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
- The lower edge of the tumors located below 12 cm from the anal verge
- Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
- No prior chemotherapy was used
- No history of regional radiation treatment inthe pelvic cavity
- Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN
- Patients without peripheral neuropathy
Exclusion Criteria:
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- Rectal cancer patients with concurrent colon cancer
- Pregnant or lactating women
- Fertile female patients without using any contraceptives
- Allergic to cisplatin and fluorouracil
- Patients with previous peripheral neuropathy
- Serious complications: myocardial infarction, heart failure (NYHA Classification>II grade),psychiatric history and severe diabetes
- Treatment with other anti-cancer therapy(including Chinese herbal medicine)
- Organ transplant patients
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab plus chemoradiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Pathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
Secondary Outcome Measures
tumor regression rate
local recurrence rate
overall survival
sphincter preservation rate
Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01899118
Brief Title
Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Official Title
A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer
Keywords
locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Nimotuzumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab plus chemoradiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Preoperative irradiation
Intervention Description
50.4Gy/28F/5.5w
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
400mg/w，0-5w
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130mg/m2 d1
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
825mg/m2 bid d1-5/w,1-5w
Primary Outcome Measure Information:
Title
Pathology complete remission rate
Description
Pathology complete remission rate is the primary outcome measure.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
tumor regression rate
Time Frame
1 year
Title
local recurrence rate
Time Frame
5 years
Title
overall survival
Time Frame
5 years
Title
sphincter preservation rate
Time Frame
3 years
Title
Incidence of Adverse Events
Time Frame
up to 1 month after the last cycle
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:
Written informed consent
Age:18-75 years
Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
The lower edge of the tumors located below 12 cm from the anal verge
Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
No prior chemotherapy was used
No history of regional radiation treatment inthe pelvic cavity
Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN
Patients without peripheral neuropathy
Exclusion Criteria:
Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
Rectal cancer patients with concurrent colon cancer
Pregnant or lactating women
Fertile female patients without using any contraceptives
Allergic to cisplatin and fluorouracil
Patients with previous peripheral neuropathy
Serious complications: myocardial infarction, heart failure (NYHA Classification>II grade),psychiatric history and severe diabetes
Treatment with other anti-cancer therapy(including Chinese herbal medicine)
Organ transplant patients
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jialin Luo, MD
Phone
0086-571-88122062
First Name & Middle Initial & Last Name & Degree
Yuan Zhu, PhD
12. IPD Sharing Statement
Learn more about this trial
Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
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