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

Phase 2

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Radiation: Preoperative irradiation; Drug: Nimotuzumab; Drug: Oxaliplatin; Drug: Capecitabine

• Registration Number: NCT01899118
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Last Update Submitted: 2013-07-12
• Study First Posted: 2013-07-15
• Last Update Posted: 2013-07-15
• Primary Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab plus chemoradiotherapy	Capecitabine	-
Nimotuzumab plus chemoradiotherapy	Preoperative irradiation	-
Nimotuzumab plus chemoradiotherapy	Nimotuzumab	-
Nimotuzumab plus chemoradiotherapy	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Pathology complete remission rate	1 year	Pathology complete remission rate is the primary outcome measure.

Secondary Outcome Measures

Name	Time	Method
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
tumor regression rate	1 year

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China