Status:
UNKNOWN
Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 sp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01899118
Start Date
April 1 2013
Last Update
July 15 2013
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022