Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 7:42 AM
Study NCT ID:
NCT01391260
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2011-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-01', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-07-08', 'lastUpdatePostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate (RR)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years'}, {'measure': 'Quality of life (MD-Anderson questionnaire)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Locally Advanced NSCLC', 'EGFR Mutation Positive', 'Radiotherapy combined Gefitinib'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.', 'detailedDescription': 'Worldwide more than half a million new cases of lung cancer are diagnosed annually. About 80% of these tumours are of non-small cell histological type. Surgery is the treatment of choice, but only about 20% of tumours are suitable for potentially curative resection. Concurrent chemoradiotherapy is the standard treatment for locally advanced NSCLC. When Iressa was used in the first-line treatment of advanced NSCLC with EGFR mutations positive, the 12-month rates of progression-free survival were 24.9%. Therefore, we speculate that the EGFR mutations in patients with locally advanced NSCLC, Gefitinib combined with radiotherapy may be better than chemoradiotherapy. We design the study to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of non-squamous NSCLC; Stage ⅢA-ⅢB(not suitable for surgery) or stage Ⅳ(only single-site single transfer );\n* Untreated patients, or who completed ≤ 2 cycles of first-line chemotherapy (chemotherapy regimen: paclitaxel, docetaxel + cisplatin) within the previous month;\n* Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation);\n* Patients must be informed of the investigational nature of the study and must sign an informed consent form;\n* Presence of at least one measurable/evaluable according to RECIST criteria.\n* ECOG performance Status 0-2 ;\n* Patients must have a life expectancy \\> 12 weeks;\n* Patients with laboratory values as follows:WBC\\>4.0 x 109/L; ANC≥1.5 x 109/L; PLT≥100 x 109/L; HGB≥10 g/dL; CR≤1.5 x ULN; TBIL\\<1.5 x ULN; AST and ALT≤1.5 x ULN; LDH≤1.5 x ULN; AKP≤5 x ULN;\n* FEV 1≥1.0L and \\>50% Corresponding normal values;\n* Patient candidate to standard platinum-based chemotherapy;\n* Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.\n\nExclusion Criteria:\n\n* Any evidence of clinically active interstitial lung disease;\n* Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin；\n* Pregnancy or lactating；\n* Serious concomitant infection;\n* MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia;\n* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease);\n* Patients who are not suitable to participate in the trial according to researchers.'}, 'identificationModule': {'nctId': 'NCT01391260', 'briefTitle': 'Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZhuGuangYing'}, 'officialTitle': 'A Phase II Trial of Radiation Therapy Combined With Iressa in Patients With Locally Advanced Non-small Cell Lung Cancer With Harboring Active EGFR Mutations', 'orgStudyIdInfo': {'id': 'CS-S10-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy Combined With Gefitinib', 'interventionNames': ['Other: Gefitinib']}], 'interventions': [{'name': 'Gefitinib', 'type': 'OTHER', 'otherNames': ['Iressa'], 'description': 'Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;', 'armGroupLabels': ['Radiotherapy Combined With Gefitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ge Shen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '307 Hosptial of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '266000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lvhua Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese Academy of Medical Sciences Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qibin Song', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renmin Hospital of Wuhan University, Hubei General Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Fan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shenglin Ma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100000', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangying Zhu', 'role': 'CONTACT', 'email': 'zgypu@yahoo.com.cn'}, {'name': 'Rong Yu', 'role': 'CONTACT', 'email': 'yurong311@yahoo.cn'}, {'name': 'Guangying Zhu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yu Rong', 'role': 'CONTACT', 'email': 'yurong311@yahoo.cn'}], 'overallOfficials': [{'name': 'Zhu Guangying', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZhuGuangYing', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': '307 Hospital of PLA', 'class': 'OTHER'}, {'name': 'Beijing Clinical Service Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Zhu Guangying', 'oldOrganization': 'Beijing Cancer Hospital'}}}}