A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Preoperative irradiation
- Conditions
- Locally Advanced Rectal Cancer
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pathology complete remission rate
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Nimotuzumab plus chemoradiotherapy
Intervention: Preoperative irradiation
Nimotuzumab plus chemoradiotherapy
Intervention: Nimotuzumab
Nimotuzumab plus chemoradiotherapy
Intervention: Oxaliplatin
Nimotuzumab plus chemoradiotherapy
Intervention: Capecitabine
Outcomes
Primary Outcomes
Pathology complete remission rate
Time Frame: 1 year
Pathology complete remission rate is the primary outcome measure.
Secondary Outcomes
- Incidence of Adverse Events(up to 1 month after the last cycle)
- local recurrence rate(5 years)
- overall survival(5 years)
- sphincter preservation rate(3 years)
- tumor regression rate(1 year)