Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-03-03 @ 9:08 PM
Study NCT ID:
NCT03392103
Status:
UNKNOWN
Last Update Posted:
2018-01-05
First Post:
2017-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C068874', 'term': 'raltitrexed'}, {'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-04', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of patients occured Grade 3 or higher adverse events', 'timeFrame': 'From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT.'}], 'secondaryOutcomes': [{'measure': '2-year local-regionally recurrence rate', 'timeFrame': '2 year', 'description': 'The probability of locally and/or regionally recurrence at 2 year after CRT on imaging or pathological examination.'}, {'measure': '3-year local-regionally recurrence rate', 'timeFrame': '3 year', 'description': 'The probability of locally and/or regionally recurrence at 3 year after CRT on imaging or pathological examination.'}, {'measure': '2-year disease-free survival probability', 'timeFrame': '2 year', 'description': 'The probability of staying free from recurrence at 2 year after CRT on imaging or pathological examination.'}, {'measure': '3-year disease-free survival probability', 'timeFrame': '3 year', 'description': 'The probability of staying free from recurrence at 3 year after CRT on imaging or pathological examination.'}, {'measure': '2-year overall survival probability', 'timeFrame': '2 year', 'description': 'The probability of staying alive at 2 year after CRT.'}, {'measure': '3-year overall survival probability', 'timeFrame': '3 year', 'description': 'The probability of staying alive at 3 year after CRT.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Raltitrexed', 'IMRT'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent signed.;\n2. Age: 18-70 years old, sex is not restricted;\n3. Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation;\n4. Received D0 or D1 operation, no tumor residual (R0);\n5. Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;\n6. ECOG 0-2;\n7. Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;\n8. Liver function: ALT or AST is less than or equal to 2.5 times of the normal high value (ULN); bilirubin is less than 1.5\\*ULN, serum APK is less than 2.5 \\* ULN;\n9. Renal function: serum creatinine is less than 1.5 \\* ULN, and creatinine clearance rate is more than 60ml/min;\n10. No previous chemotherapy or radiation therapy history;\n11. No organ transplant history;\n12. Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;\n13. Men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before , during and after the course of the study\n\nExclusion Criteria:\n\n1. Received D2 radical operation;\n2. Tumor residual (R1/R2);\n3. There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;\n4. Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;\n5. Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;\n6. Anticipate other clinical trials in four weeks before enrollment.\n7. Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.\n8. Drug abuse history or alcohol addiction;\n9. Active infection existed.\n10. with severe malnutrition or severe anemia;\n11. Human immunodeficiency virus (HIV) infection;\n12. Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;\n13. Can not tolerate this study or may be allergic to the drug used in this study;\n14. Persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.'}, 'identificationModule': {'nctId': 'NCT03392103', 'briefTitle': 'Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection', 'orgStudyIdInfo': {'id': 'HCCSC G03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'postoperative CRT', 'description': 'postoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4).', 'interventionNames': ['Drug: Raltitrexed', 'Radiation: postoperative radiotherapy']}], 'interventions': [{'name': 'Raltitrexed', 'type': 'DRUG', 'otherNames': ['Raltitrexed Injectable Solution'], 'description': 'concurrent chemotherapy', 'armGroupLabels': ['postoperative CRT']}, {'name': 'postoperative radiotherapy', 'type': 'RADIATION', 'otherNames': ['adjuvant radiotherapy'], 'description': 'concurrent postoperative radiation therapy', 'armGroupLabels': ['postoperative CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fuxiang Zhou, M.D.', 'role': 'CONTACT', 'email': 'fuxiang.zhou@whu.edu.cn', 'phone': '+86（0）2767813155'}, {'name': 'Jing Dai, M.D.', 'role': 'CONTACT', 'email': 'daijing1116@163.com', 'phone': '+86（0）2767813155'}], 'facility': 'Zhongnan Hopital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Jing Dai, M.D.', 'role': 'CONTACT', 'email': 'daijing1116@163.com', 'phone': '+86（0）2767813155'}, {'name': 'Ling Xai, M.D.', 'role': 'CONTACT', 'email': '22425583@qq.com', 'phone': '+86（0）2767813155'}], 'overallOfficials': [{'name': 'Fuxiang Zhou, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongnan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Zhou Fuxiang', 'investigatorAffiliation': 'Zhongnan Hospital'}}}}