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

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

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.

Study Overview

• Status: Unknown
• Conditions: Locally Advanced Rectal Cancer
• Intervention / Treatment: Radiation: Preoperative irradiation; Drug: Nimotuzumab; Drug: Oxaliplatin; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer hospital
      • Principal Investigator: Yuan Zhu, PhD
      • Contact: Jialin Luo, MD; Phone Number: 0086-571-88122062

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent
2. Age:18-75 years
3. Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
4. The lower edge of the tumors located below 12 cm from the anal verge
5. Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
6. No prior chemotherapy was used
7. No history of regional radiation treatment inthe pelvic cavity
8. 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
9. Patients without peripheral neuropathy

Exclusion Criteria:

1. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
2. Rectal cancer patients with concurrent colon cancer
3. Pregnant or lactating women
4. Fertile female patients without using any contraceptives
5. Allergic to cisplatin and fluorouracil
6. Patients with previous peripheral neuropathy
7. Serious complications: myocardial infarction, heart failure (NYHA Classification>II grade),psychiatric history and severe diabetes
8. Treatment with other anti-cancer therapy(including Chinese herbal medicine)
9. Organ transplant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: locally advanced rectal cancer; Nimotuzumab; Neoadjuvant chemoradiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Capecitabine; Oxaliplatin; Nimotuzumab
• Other Study ID Numbers: ZhejiangCH-ARO2013