Clinical trial NCT01899118: Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Official title: A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Rectal Cancer
Keywords: locally advanced rectal cancer
Neoadjuvant chemoradiotherapy
Nimotuzumab
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pathology complete remission rate
timeFrame: 1 year
Secondary outcomes:
measure: tumor regression rate
timeFrame: 1 year
measure: local recurrence rate
timeFrame: 5 years
measure: overall survival
timeFrame: 5 years
measure: sphincter preservation rate
timeFrame: 3 years
measure: Incidence of Adverse Events
timeFrame: up to 1 month after the last cycle
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: