Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

Conditions
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Locally Advanced Rectal Cancer

Intervention / Treatment
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* Radiation: Preoperative irradiation
* Drug: Nimotuzumab
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab plus chemoradiotherapy<br> | Radiation: Preoperative irradiation<br>* 50.4Gy/28F/5.5w<br>Drug: Nimotuzumab<br>* 400mg/w，0-5w<br>Drug: Oxaliplatin<br>* 130mg/m2 d1<br>Drug: Capecitabine<br>* 825mg/m2 bid d1-5/w,1-5w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology complete remission rate | Pathology complete remission rate is the primary outcome measure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor regression rate |  | 1 year | 
| local recurrence rate |  | 5 years | 
| overall survival |  | 5 years | 
| sphincter preservation rate |  | 3 years | 
| Incidence of Adverse Events |  | up to 1 month after the last cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Nimotuzumab