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

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01899118

Collaborator

(none)

Enrollment

Location

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Radiation: Preoperative irradiation Drug: Nimotuzumab Drug: Oxaliplatin Drug: Capecitabine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pathology complete remission rate [1 year]
Pathology complete remission rate is the primary outcome measure.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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