Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT01899118
Status:
UNKNOWN
Last Update Posted:
2013-07-15
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C501466', 'term': 'nimotuzumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-12', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathology complete remission rate', 'timeFrame': '1 year', 'description': 'Pathology complete remission rate is the primary outcome measure.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['locally advanced rectal cancer', 'Neoadjuvant chemoradiotherapy', 'Nimotuzumab'], 'conditions': ['Locally Advanced Rectal Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent\n2. Age:18-75 years\n3. Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)\n4. The lower edge of the tumors located below 12 cm from the anal verge\n5. Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months\n6. No prior chemotherapy was used\n7. No history of regional radiation treatment inthe pelvic cavity\n8. 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\n9. Patients without peripheral neuropathy\n\nExclusion Criteria:\n\n1. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ\n2. Rectal cancer patients with concurrent colon cancer\n3. Pregnant or lactating women\n4. Fertile female patients without using any contraceptives\n5. Allergic to cisplatin and fluorouracil\n6. Patients with previous peripheral neuropathy\n7. Serious complications: myocardial infarction, heart failure (NYHA Classification\\>II grade),psychiatric history and severe diabetes\n8. Treatment with other anti-cancer therapy(including Chinese herbal medicine)\n9. Organ transplant patients'}, 'identificationModule': {'nctId': 'NCT01899118', 'briefTitle': 'Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'ZhejiangCH-ARO2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimotuzumab plus chemoradiotherapy', 'interventionNames': ['Radiation: Preoperative irradiation', 'Drug: Nimotuzumab', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Preoperative irradiation', 'type': 'RADIATION', 'description': '50.4Gy/28F/5.5w', 'armGroupLabels': ['Nimotuzumab plus chemoradiotherapy']}, {'name': 'Nimotuzumab', 'type': 'DRUG', 'description': '400mg/w，0-5w', 'armGroupLabels': ['Nimotuzumab plus chemoradiotherapy']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': '130mg/m2 d1', 'armGroupLabels': ['Nimotuzumab plus chemoradiotherapy']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': '825mg/m2 bid d1-5/w,1-5w', 'armGroupLabels': ['Nimotuzumab plus chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jialin Luo, MD', 'role': 'CONTACT', 'phone': '0086-571-88122062'}, {'name': 'Yuan Zhu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}