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

NCT ID: NCT01899118

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab plus chemoradiotherapy

Group Type: EXPERIMENTAL

Preoperative irradiation

Intervention Type: RADIATION

50.4Gy/28F/5.5w

Nimotuzumab

Intervention Type: DRUG

400mg/w，0-5w

Oxaliplatin

Intervention Type: DRUG

130mg/m2 d1

Capecitabine

Intervention Type: DRUG

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

Interventions

Preoperative irradiation

50.4Gy/28F/5.5w

Intervention Type: RADIATION

Nimotuzumab

400mg/w，0-5w

Intervention Type: DRUG

Oxaliplatin

130mg/m2 d1

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jialin Luo, MD

Role: primary

0086-571-88122062

Other Identifiers

ZhejiangCH-ARO2013

Identifier Type: -

Identifier Source: org_study_id