Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-03 @ 12:26 PM
Study NCT ID:
NCT03791905
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized parallel study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2018-12-31', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical complete response', 'timeFrame': '3 months after the treatment (plus or minus 7 days)', 'description': 'RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years after randomization', 'description': 'From the enrollment to the date of death from any cause or date of lost follow-up'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years after randomization', 'description': 'From the date of randomization to the date of disease progression or last follow-up'}, {'measure': 'Chemoradiotherapy-related toxicity', 'timeFrame': 'From the date of randomization to the 3 months after treatment', 'description': 'Treatment-related toxicity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal squamous cell carcinoma', 'PET', 'Definitive chemoradiotherapy', 'Induction chemotherapy'], 'conditions': ['Neoplasm, Esophageal', 'Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '27152857', 'type': 'RESULT', 'citation': 'Ku GY, Kriplani A, Janjigian YY, Kelsen DP, Rusch VW, Bains M, Chou J, Capanu M, Wu AJ, Goodman KA, Ilson DH. Change in chemotherapy during concurrent radiation followed by surgery after a suboptimal positron emission tomography response to induction chemotherapy improves outcomes for locally advanced esophageal adenocarcinoma. Cancer. 2016 Jul 1;122(13):2083-90. doi: 10.1002/cncr.30028. Epub 2016 May 6.'}]}, 'descriptionModule': {'briefSummary': 'Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. The aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on PET response to induction chemotherapy can improve clinical complete response (cCR) in patients with unresectable esophageal squamous cell carcinoma (ESCC).', 'detailedDescription': 'A total of 216 patients with baseline PET scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (TP) on days 1, 22 or FOLFOX (oxaliplatin, leucovorin, 5-FU) on days 1, 15, 29. Repeat PET was performed on days 36-42 and changes in max standardized uptake value (SUVmax) from baseline were assessed. Using a predefined cut-off value of a 35% decrease in SUVmax, PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\\<35% decrease in SUVmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions, 5 days per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma of the esophagus;\n2. Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);\n3. Not suitable for surgery (either for medical reasons or patient's choice);\n4. Age at diagnosis 18 to 70 years;\n5. Eastern Cooperative Oncology Group performance status ≤ 2\n6. No prior cancer therapy;\n7. No history of concomitant or previous malignancy;\n8. Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;\n9. Renal function: Cr ≤ 1.25×UNL;\n10. Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;\n11. Documented informed consent to participate in the trial.\n\nExclusion Criteria:\n\n1. Younger than 18 or older than 70 years of age;\n2. ECOG performance status of 3 or above;\n3. Other cancer history;\n4. Previous radiotherapy history;\n5. Subjects with distant metastases;\n6. Pregnancy or breast feeding. Women of childbearing age must use effective contraception;\n7. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);\n8. Evidence of bleeding diathesis or serious infection."}, 'identificationModule': {'nctId': 'NCT03791905', 'briefTitle': 'PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Phase II Randomized Trial of PET Imaging in Assessing Response to Induction Chemotherapy in Esophageal Squamous Cell Carcinoma Treated With Definitive Chemoradiotherapy', 'orgStudyIdInfo': {'id': 'PETESCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TP Arm', 'description': 'Patients with baseline PET scan assigned to this Arm will receive two cycles of 3-weekly schedule of induction chemotherapy with paclitaxel/cisplatin (TP), consisting of paclitaxel 150 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\\<35% decrease in SUVmax) crossed over to FOLFOX regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Cisplatin', 'Radiation: Intensity-modulated radiotherapy', 'Device: PET']}, {'type': 'EXPERIMENTAL', 'label': 'FOLFOX Arm', 'description': 'Patients with baseline PET scan assigned to this Arm will receive three cycles of 2-weekly schedule of induction chemotherapy with FOLFOX (oxaliplatin, leucovorin, 5-FU), consisting of oxaliplatin 85 mg/m2 on day 1, leucovorin 400 mg/m2, and 5-FU 2 g/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\\<35% decrease in SUVmax) crossed over to TP regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: 5-FU', 'Drug: Leucovorin', 'Radiation: Intensity-modulated radiotherapy', 'Device: PET']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'chemotherapy drug', 'armGroupLabels': ['TP Arm']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['DDP'], 'description': 'chemotherapy drug', 'armGroupLabels': ['TP Arm']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['OXA'], 'description': 'chemotherapy drug', 'armGroupLabels': ['FOLFOX Arm']}, {'name': '5-FU', 'type': 'DRUG', 'otherNames': ['Fluorouracil'], 'description': 'chemotherapy drug', 'armGroupLabels': ['FOLFOX Arm']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['CF'], 'description': 'chemotherapy drug', 'armGroupLabels': ['FOLFOX Arm']}, {'name': 'Intensity-modulated radiotherapy', 'type': 'RADIATION', 'otherNames': ['IMRT'], 'description': 'radiotherapy technique', 'armGroupLabels': ['FOLFOX Arm', 'TP Arm']}, {'name': 'PET', 'type': 'DEVICE', 'otherNames': ['PET-CT'], 'description': 'Using PET to evaluate response to induction chemotherapy', 'armGroupLabels': ['FOLFOX Arm', 'TP Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mian Xi, MD', 'role': 'CONTACT', 'email': 'ximian@sysucc.org.cn', 'phone': '+86-20-87343385'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}], 'centralContacts': [{'name': 'Mian XI, MD', 'role': 'CONTACT', 'email': 'ximian@sysucc.org.cn', 'phone': '+86-20-87343385'}, {'name': 'Mengzhong Liu, MD', 'role': 'CONTACT', 'email': 'liumzh@sysucc.org.cn', 'phone': '+86-20-87343385'}], 'overallOfficials': [{'name': 'Mian XI, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mian XI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Preofessor', 'investigatorFullName': 'Mian XI', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}