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

NCT01899118 | Unknown Phase 2 DMC

• 1 other identifier: ZhejiangCH-ARO2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer

Keywords

locally advanced rectal cancer; Neoadjuvant chemoradiotherapy; Nimotuzumab

Outcome Measures

Primary Outcomes (1)

• Pathology complete remission rate

  Pathology complete remission rate is the primary outcome measure.

  1 year

Secondary Outcomes (5)

• 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

Study Arms (1)

Nimotuzumab plus chemoradiotherapy

EXPERIMENTAL

Radiation: Preoperative irradiation; Drug: Nimotuzumab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Preoperative irradiation RADIATION

50.4Gy/28F/5.5w

Nimotuzumab plus chemoradiotherapy

Nimotuzumab DRUG

400mg/w，0-5w

Nimotuzumab plus chemoradiotherapy

Oxaliplatin DRUG

130mg/m2 d1

Nimotuzumab plus chemoradiotherapy

Capecitabine DRUG

825mg/m2 bid d1-5/w,1-5w

Nimotuzumab plus chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

nimotuzumab; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 15, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

CN (1)