Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-02 @ 4:37 PM
Study NCT ID:
NCT02193594
Status:
UNKNOWN
Last Update Posted:
2015-06-08
First Post:
2014-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The pathologic profiles and the pathologic response rates', 'timeFrame': 'Within 30 days after the day of operation', 'description': 'the pathologic profiles and the pathologic response rates'}], 'primaryOutcomes': [{'measure': "The patient's survival time and recurrence time", 'timeFrame': 'Up to 3 years', 'description': '3-year overall survival\n\n1-year and 3-year recurrence free survival'}], 'secondaryOutcomes': [{'measure': 'The number of patients with complications', 'timeFrame': 'Within 30 days after the day of operation', 'description': 'the morbidity and mortality rates within 30 days after the day of operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preoperative concurrent chemoradiotherapy', 'Neoadjuvant chemoradiotherapy', 'Gastroesophageal junction adenocarcinoma'], 'conditions': ['Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the gastroesophageal junction.\n* Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.\n* Eastern Cooperative Oncology Group (ECOG) performance status≤2.\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Combined with other malignant tumors.\n* Eastern Cooperative Oncology Group (ECOG) performance status\\>2.\n* Combined with severe organ dysfunction.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02193594', 'briefTitle': 'Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CRADLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCRT group', 'description': 'The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.', 'interventionNames': ['Radiation: Preoperative concurrent chemoradiotherapy', 'Procedure: Radical D2 total gastrectomy', 'Drug: Adjuvant chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CT group', 'description': 'The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.', 'interventionNames': ['Procedure: Radical D2 total gastrectomy', 'Drug: Adjuvant chemotherapy']}], 'interventions': [{'name': 'Preoperative concurrent chemoradiotherapy', 'type': 'RADIATION', 'otherNames': ['CCRT', 'Eloxatin®', 'S-1®'], 'description': 'The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.', 'armGroupLabels': ['CCRT group']}, {'name': 'Radical D2 total gastrectomy', 'type': 'PROCEDURE', 'description': 'Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.', 'armGroupLabels': ['CCRT group', 'CT group']}, {'name': 'Adjuvant chemotherapy', 'type': 'DRUG', 'otherNames': ['Eloxatin®', 'S-1®'], 'description': 'Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA\\<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA\\>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.', 'armGroupLabels': ['CCRT group', 'CT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Haidian District', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuangxi Li, M.D.', 'role': 'CONTACT', 'email': 'lishuangxi@outlook.com'}, {'name': 'Jiafu Ji, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ziyu Li, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shuangxi Li, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital'}], 'centralContacts': [{'name': 'Jiafu Ji, M.D.', 'role': 'CONTACT', 'email': 'jiafuj@hotmail.com'}], 'overallOfficials': [{'name': 'Jiafu Ji, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory)', 'investigatorFullName': 'Jiafu Ji', 'investigatorAffiliation': 'Peking University'}}}}