Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 7:46 AM
Study NCT ID:
NCT00941135
Status:
TERMINATED
Last Update Posted:
2011-09-29
First Post:
2009-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-28', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Laryngeal Neoplasms']}, 'descriptionModule': {'briefSummary': 'To evaluate the progression free time in patients with completed or partial response \\> 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient informed consent must be signed before to start the study.\n* Age between 18 to 70 years.\n* Performance Status 0-1 according to ECOG scale at the moment of inclusion.\n* Life expectancy \\>3 months.\n* Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx carcinoma III or IV stage without evidence of distance metastasis, which surgery involve a total laryngectomy.\n* T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both locations it will be required III or IVA stage.\n* Patients in medical conditions to receive neoadjuvant treatment with TPF followed by hyperfractionated radiotherapy combined with cetuximab.\n* Presence of a injury measurable with RECIST criteria.\n* Neutrophils \\> or = 1500/mm3, platelets \\> or = 150.000/mm3 and haemoglobin \\> or =10 g/dL.\n* Renal Function appropriate\n* Hepatic Function appropriate\n* Serum Calcium tight to albumine \\< or = 1,25 x upper normal limit (UNL).\n* Nutritional status appropriate: weight loss \\< 20% and albumine \\> or = 35 g/L.\n* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.\n\nExclusion Criteria:\n\n* Metastatic disease.\n* Surgical treatment, radiotherapy and/or previous chemotherapy.\n* Another tumour locations in head and neck area different from larynx or hypo larynx.\n* Another stages different from III or IVa without distant metastasis and resectable disease.\n* Another previous scaly carcinoma\n* Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ and/or basocellular cutaneous carcinoma adequately treated.\n* Active infection treated by ATB IV, including active tuberculosis and VIH.\n* Hypertension not controled defined as systolic \\> or = 180 mm Hg and/or diastolic \\> or =130 mm Hg at rest.\n* Pregnant/lactating women.\n* Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.\n* Another antineoplastics concomitant treatments.\n* Coronary artery disease or history of heart attack in the last 12 months or high risk of arrythmia uncontrolled or cardiac insufficiency uncontrolled.\n* EPOC that required more than 3 hospitalizations in the last 12 months.\n* Active ulcus not controled.\n* Psychiatric illness/social situations that would limit compliance with study requirements\n* Drug abuse (except alcohol abuse)\n* Knowledge of Allergic to study treatment.\n* Previous treatment with Monoclonal antibodies.\n* Any experimental treatment in the previous 30 days to start the study.'}, 'identificationModule': {'nctId': 'NCT00941135', 'briefTitle': 'Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Miguel Servet'}, 'officialTitle': 'Phase II Study of TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab "Boost Concomitant" With Cetuximab in Patients With Local Advanced Larynx/Hypolarynx Carcinoma', 'orgStudyIdInfo': {'id': 'HN2008'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2008-003365-29'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab', 'type': 'OTHER', 'otherNames': ['TPF (Chemotherapy Regimen code)'], 'description': 'Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks\n\nRadiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29010', 'city': 'Málaga', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Fernando Arias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Navarra'}, {'name': 'Ruth Vera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Miguel Servet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Salutis Research, SL', 'class': 'UNKNOWN'}, {'name': 'Unidad de Genética Clínica (Clínica Universitaria de Navarra)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}