Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:17 AM
Study NCT ID:
NCT07361133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of Cyclophosphamide and Etoposide as metronomic therapy', 'timeFrame': 'From first day of the study to the end of treatment at 6 months.', 'description': 'The efficacy of Cyclophosphamide and Etoposide as metronomic therapy in improving disease response. Tumor size (tumor dimensions: length, width, height) as measured by Computed Tomography, illustrating whether the disease is progressed, regressed or stationary. In addition to serum LDH level. Both will be assessed every 3 cycles.'}], 'secondaryOutcomes': [{'measure': 'Assessment of clinical symptoms', 'timeFrame': 'From the first day of the study till the end of treatment at 6 months', 'description': 'Clinical symptoms will be assessed each cycle of treatment through assessment of pain by Numeric Pain Rating Scale, difficulty in swallowing, persistent hoarseness, weight loss.'}, {'measure': 'Progression free survival', 'timeFrame': 'From first day of the study till the end of study at 6 months', 'description': 'Evaluation of the progression free survival at the end of study'}, {'measure': 'Overall survival', 'timeFrame': 'From the first day of study till the end of study at 8 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cyclophosphamide', 'Etoposide', 'Head and neck squamous cell carcinoma', 'Advanced recurrent', 'Metastatic'], 'conditions': ['Advanced Head and Neck Squamous Cell Carcinoma', 'Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.annonc.2024.10.456', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if drugs as cyclophosphamide (C) and etoposide (E) work to treat advanced head and neck cancer in adults. It will also learn about the safety of both drugs. The main questions it aims to answer are:\n\nDo drugs C and E work to treat advanced head and neck cancer, after failure on first line chemotherapy? What medical problems do participants have when taking drugs C and E? Researchers will compare drugs C and E in combination to a placebo (a look-alike substance that contains no drug) to see if these 2 drugs works to treat advanced head and neck cancer.\n\nParticipants will:\n\nTake drug C every 3 weeks and drug E every 4 weeks or a placebo every week for 6 months.\n\nVisit the clinic once every 3 weeks for checkups and tests. Keep a diary of their symptoms.', 'detailedDescription': 'This clinical trial aims to evaluate the potential efficacy of cyclophosphamide and etoposide as metronomic therapy in recurrent/resistant and/or metastatic head and neck squamous cell carcinoma adults after failure on first line chemotherapy, or intolerant to further aggressive chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants, age = or \\> 18 years\n* Participants with recurrent head and neck squamous cell carcinoma after failure on first line chemotherapy.\n* Participants with advanced progressed, resistant, metastatic head and neck squamous cell carcinoma.\n\nExclusion Criteria:\n\n* Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.'}, 'identificationModule': {'nctId': 'NCT07361133', 'briefTitle': 'Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'MO 2504-505-120-198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclophosphamide and Etoposide in combination', 'description': 'Participants in intervention arm will receive cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks, for total 6 months.', 'interventionNames': ['Drug: Cyclophosphamide and Etoposide in combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate', 'description': 'Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months.', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Cyclophosphamide and Etoposide in combination', 'type': 'DRUG', 'description': 'Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.', 'armGroupLabels': ['Cyclophosphamide and Etoposide in combination']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': '50 mg weekly for 6 months', 'armGroupLabels': ['Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Zeinab Hassan', 'role': 'CONTACT', 'email': 'zeinab.hassan@nci.cu.edu.eg', 'phone': '00201021419716'}], 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahitab Gamal', 'role': 'CONTACT', 'email': 'mahitab2526@gmail.com', 'phone': '00201119668735'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participants data can not be shared for patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}