Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:40 AM
Study NCT ID:
NCT07399158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Response to Induction Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 223}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-02-07', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'Baseline, 1 year, 2 years, 3 years', 'description': 'The primary endpoint of this study is to compare the 3-year progression-free survival (PFS) rate between the two treatment groups. Disease progression will be assessed using RECIST 1.1 criteria, with imaging exams (such as MRI) used to monitor tumor size and progression.'}], 'secondaryOutcomes': [{'measure': 'Local Regional Recurrence-Free Survival', 'timeFrame': 'Baseline, 1 year, 2 years, 3 years', 'description': 'This secondary endpoint will evaluate the 3-year local regional recurrence-free survival (LRRFS) rate between the two treatment groups.'}, {'measure': 'Overall Survival', 'timeFrame': 'Baseline, 1 year, 2 years, 3 years', 'description': 'This secondary endpoint will evaluate the 3-year overall survival (OS) rate. The OS rate will be compared between the re-induction chemotherapy followed by radiotherapy group and the direct radiotherapy group.'}, {'measure': 'Distant Metastasis-Free Survival', 'timeFrame': 'Baseline, 1 year, 2 years, 3 years', 'description': 'This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate.'}, {'measure': 'Complete Response Rate after Radiotherapy', 'timeFrame': '3 months post-treatment', 'description': 'This secondary endpoint will assess the rate of complete response (CR) after radiotherapy.'}, {'measure': '3-4 Grade Acute Toxicity Incidence', 'timeFrame': 'through study completion, an average of 4-6 months', 'description': 'This secondary endpoint will assess the incidence of grade 3 or 4 acute toxicity, based on the Common Terminology Criteria for Adverse Events (CTCAE) scale. The toxicity will be assessed during the course of the treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include patients aged 18-70 years with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III) and no distant metastasis. Eligible participants must have completed two cycles of standard induction chemotherapy (e.g., TPF, GP, or TP), and the post-induction treatment evaluation must show stable disease (SD) or disease progression (PD) according to RECIST 1.1 criteria. Patients should have an ECOG Performance Status (PS) of 0-1 and adequate bone marrow, liver, and kidney function to tolerate concurrent chemoradiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 18 to 70 years old.\n\nHistologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III).\n\nInitial treatment with no distant metastasis: Locally advanced nasopharyngeal carcinoma (according to the AJCC/UICC 9th edition staging, stage II-III, i.e., T3-4N0-3M0 or T1-2N2-3M0).\n\nCompletion of two cycles of standard induction chemotherapy (such as TPF, GP, TP, etc.).\n\nPost-induction chemotherapy evaluation: Disease stability (SD) or disease progression (PD) after two cycles of induction chemotherapy, as assessed by RECIST 1.1 criteria, based on enhanced MRI of the nasopharynx.\n\nECOG Performance Status (PS): 0-1.\n\nBone marrow, liver, and kidney function: Sufficient to tolerate concurrent chemoradiotherapy (specific criteria to be referenced).\n\nInformed consent: Voluntary participation in the study and signing of written informed consent.\n\nExclusion Criteria:\n\nHistory of head and neck tumor radiotherapy or any other malignant cancer history (except for cured non-melanoma skin cancer).\n\nPartial response (PR) or complete response (CR) after induction chemotherapy.\n\nSevere uncontrolled comorbidities, such as unstable angina, congestive heart failure, severe chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes mellitus.\n\nActive infection or severe immunodeficiency diseases.\n\nPregnant or breastfeeding women.\n\nAny mental or social disorders that may interfere with study evaluation or compliance.\n\nOther conditions deemed by the investigator to be unsuitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT07399158', 'briefTitle': 'CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Response to Induction Chemotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'CROSSROAD: A Prospective Multicenter Observational Study on the Efficacy of Treatment Regimen Switch With Re-induction Chemotherapy Versus Direct Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Inadequate Response (SD/PD) After Induction Chemotherapy', 'orgStudyIdInfo': {'id': '2026-01-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Re-induction Chemotherapy Group', 'description': 'This group consists of patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. These patients will receive re-induction chemotherapy followed by radiotherapy as part of their treatment regimen.'}, {'label': 'Direct Radiotherapy Group', 'description': 'This group consists of patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. These patients will receive direct radiotherapy without re-induction chemotherapy.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yedong Huang, MD. PhD', 'role': 'CONTACT', 'email': 'drhuangyd@163.com', 'phone': '+86 15959678182'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Head and Neck Radiation Oncology, Clinical Professor', 'investigatorFullName': 'Qiaojuan Guo', 'investigatorAffiliation': 'Fujian Cancer Hospital'}}}}